Lot Numbers: 31480713, 31480721, 31968743, 31971619, 31990844, 32005711, 32018491, 32037764, 32118020, 32710832, 32736223, 33053264, 33105221, 33141176, 33164204, 33164407, 33276273, 33329911

Physical Medicine Devices

2

No

Nationwide Distribution.

Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. || Physical Therapy.

REF 50-12127: Lot numbers: 36207249, 36396502, 36912175, 38441725;   REF 53-1931: Lot numbers: 33718713, 34910141, 34939139, 35588220, 35814688, 35850671, 35850689, 35862524, 36047791, 36095291, 36517319, 36746146, 36753451, 36517319, 37137174, 36917953, 37581806, 37700140, 37854413, 37794561, 37994256, 38180166, 38222135, 38250970, 38266955, 38475255, 38518382, 36917953;  REF 53-1932: Lot numbers: 34374561, 34374570, 34374561, 34492891, 34740023, 34740031, 34910133, 34939067, 34910133, 34939067, 35031309, 35170747, 35503361, 35128080, 35503361, 35128080, 35531442, 35850654, 35850662, 35531442, 35850662, 35862532, 36095267, 36139733, 36426151, 36426169, 36464675, 36746154, 36753442, 36917945, 36746154, 36962762, 37137182, 37137238, 37246240, 37259219, 37287586, 37700123, 37287586, 37581785, 37700158, 37794553, 37869762, 37994230, 38222127, 37700158, 37794553, 37994248, 38222127, 38250945, 38266947, 38475263, 38518374, 37137182, 37259219;   53-1933: Lot numbers: 33718705, 34374545, 34492912, 34939059, 34910125, 34939059, 35086692, 35503337, 35850638, 35850646, 36095259, 36426142, 36746138, 36753434, 36917937, 36962771, 37137166, 37259180, 37287594, 37581769, 37581777, 37854405, 37854421, 37869771, 38467888, 38250937, 37259180;  REF 5-3479-1: Lot numbers: 1346014X, 2002010X;  REF 89-3605: Lot numbers: 35199494, 35332531, 33714317, 34508890, 34588789, 34701278, 34508890, 35609158, 35733546, 35199494, 35332531, 35609158, 36020265, 36318555, 37012777, 37197994, 37866668, 36740916, 37392423, 37478286, 37652467, 38007267, 38185784, 38497500, 38678503, 34508890;   REF 89-3606: Lot numbers: 38086153, 33671273, 33477059, 33804611, 34588797, 34883729, 34508902, 35609166, 35733562, 35095337, 35399517, 35244161, 36053948, 36395614, 36421448, 37198006, 36813661, 37150213, 36665135, 37012785, 37454874, 37652475, 37866676, 38007275, 38160798, 38134063, 38317871, 38275739, 38413062, 38729083;   REF 89-3607: Lot numbers: 38221298, 37221034, 33501485, 33478588, 33805577, 34447791, 34785555, 34931903, 34987561, 35610335, 34987561, 35245219, 36207337, 35848642, 36021508, 36479421, 36962244, 37198794, 37455421, 37325992, 37867791, 38086735, 38221298, 38269523, 38498140;   REF 89-3609: Lot numbers: 33671281, 34930863, 34588800, 35783990, 35332558, 36318571, 37012793, 37454882, 38086161, 38372184, 38729104;   REF 89-3610: Lot numbers: 37866705, 33618931, 33747565, 34508929, 34823689, 35244179, 35784001, 35518184, 35733589, 34959914, 35124804, 35332566, 36020290, 36137236, 36318580, 36053964, 36478428, 36911332, 36813687, 37454891, 38522306, 37267219, 37392440, 37866705, 38038514, 38086170, 38246920, 38275755, 38497526, 38831803, 38609989;  REF 89-3611: Lot numbers: 33477083, 33533698, 33692373, 33831257, 34508937, 34737422, 34737414, 35244187, 35733597, 35244195, 35487681, 35896071, 36192569, 36053972, 36478436, 37929711, 36911359, 36543808, 36740959, 37198014, 37454903, 37524060, 37588581, 37274291, 37815035, 38086188, 38185792, 38275763, 38497534, 38729121, 38522314, 38729112, 33477083, 35487681, 36478436, 37929711, 36543808, 37274291, 37815035, 38185792, 38497534;   REF 89-3808: Lot numbers: 37198815, 35734821, 33599208, 34510375, 34825140, 35734821, 35459022, 35280250, 35400451, 35734821, 35952141, 36055433, 36479439, 36579860, 36666171, 37013711, 37393080, 37525089, 37867804, 38008008, 38186138, 38221301, 38276344, 38498158, 38781949, 38729884, 35096372, 34510375;   REF 89-3809: Lot numbers: 33549278, 33748875, 34510383, 35784731, 35400469, 36666189, 36912511, 37653531, 37378963, 37867812, 38032243, 38345338, 38746246, 37867812;  REF 89-4137: Lot numbers: 33692402, 34737502;  REF 89-4798: Lot numbers: 37915888, 38086727, 38230397;  REF 89-4832: Lot numbers: 34447361, 34589941, 36479199, 37575529, 37839192, 38497948;   REF 89-4902: Lot numbers: 34631118, 34750791, 36244744, 37661398, 38401811, 38412991;   REF 89-4935: Lot numbers: 37197935, 33533612, 33618907, 33747469, 34431482, 34792675, 33888510, 34930783, 34588711, 35518109, 35659315, 35051537, 35199283, 36318491, 36137172, 36192518, 36020206, 37012742, 36911244, 36576896, 36740801, 37078531, 37454794, 37652408, 38576099, 37741961, 37814930, 37866609, 38007216, 38086102, 38142629, 38246874, 38632417, 38365380;   REF 89-5057: Lot numbers: 33669448, 34833123, 35846170, 36017998, 36316285, 37333061, 37813144;   REF 89-5059: Lot numbers: 33595653, 33474608, 33618042, 33744858, 35026497, 35242157, 35670944, 35606483, 35039589, 35330851, 35894489, 36316357, 35606483;  REF 89-5246: Lot numbers: 33549008, 35896530;  REF 89-5259: Lot numbers: 34738556, 34824737, 35518969, 35784458, 35951973, 36396473;   REF 89-5609: Lot numbers: 35072602, 35530394, 36132953, 38400051, 38737542;  REF 89-5611: Lot numbers: 35514255, 37075882, 37863264;   REF 89-5978: Lot number 37263824;  REF 89-5979: Lot numbers: 37263841, 34440291, 34682353, 35328436, 37388758;  REF 89-5985: Lot numbers: 35560892, 35740244, 34966057, 35946550, 35990921, 36568503, 37622701, 37725494, 37973033, 38219382, 38090697, 38455705, 38743934, 38689131;   REF 89-6263: Lot numbers: 38341935, 33616012, 34749079, 35479710, 36068710, 33384258, 33616012, 34749079, 35479710, 36189221, 36068710, 36569055, 37036437, 37194321, 37773496, 38341935, 38778782;   REF 89-6264: Lot numbers: 35122585, 36049851, 36132451, 36327187, 36735527, 35122585, 36327187, 36957306, 36661011, 37520376;   REF 89-6341: Lot numbers: 33740890, 35239126, 35603101, 37194494, 36735551, 37569639, 37811261;   REF 89-6354: Lot numbers: 34749159, 35239151, 37773648;  REF 89-6374: Lot numbers: 34352021, 34801412, 34858064, 35728392, 35038359, 36809848, 37194540, 37520430, 38350129, 38399811, 34352021, 34801412, 34858064, 35728392, 35038359, 36809848, 37194540, 37520430, 38350129, 38399811;   REF 89-6377: Lot numbers: 33545550, 33689140, 34352047, 34749183, 34858072, 34580402, 34983447, 35513738, 35394759, 35328727, 36049914, 35947149, 36015141, 36079996, 38263261, 36809856, 37145781, 37218249, 36569346, 37075479, 37218249, 37332324, 37463973, 37773701, 37838595, 38090734, 38166410, 37973391, 38342111, 38455941, 38518905, 38630180, 38090734, 33545550, 33689140, 34352047, 34749183, 34858072, 34580402, 34983447, 35513738, 35394759, 35328727, 36049914, 35947149, 36015141, 36079996, 38263261, 36809856, 37145781, 37218249, 36569346, 37075479, 37218249, 37332324, 37463973, 37773701, 37838595, 38090734, 38166410, 37973391, 38342111, 38455941;   REF 89-6378: Lot numbers: 35603207, 33565294, 33592188, 33616160, 33740945, 33903193, 34924535, 34352012, 34580381, 34749175, 34858048, 34429171, 34452013, 35603207, 35728384, 34983412, 35122622, 35603207, 35513711, 35328680, 35858808, 35967983, 36262176, 36132540, 36391277, 36473387, 36569311, 36809830, 37145756, 36674955, 37009332, 37520421, 37264270, 37389021, 37773664, 37838587, 38131735, 38084060, 38243930, 38273645, 38495176, 38575504, 35603207, 33565294, 33592188, 33616160, 33740945, 33903193, 34924535, 34352012, 34580381, 34749175, 34858048, 34429171, 34452013, 35603207, 35728384, 34983412, 35122622, 35603207, 35513711, 35328680, 35858808, 35967983, 36262176, 36132540, 36391277, 36473387, 36569311, 36809830, 37145756, 36674955, 37009332, 37520421, 37264270, 37389021, 37773664, 37838587, 38131735, 38084060, 38243930, 38273645;    REF 89-6396: Lot numbers: 33592111, 35513640, 37126993, 36868856, 36735535, 37194451, 38495141;  REF 89-6409: Lot number 36717054;  REF 89-6508: Lot numbers: 36818058, 37217975, 35887289, 33566422, 33688884, 33528400, 33828816, 34523838, 34351749, 34857651, 34868650, 35887289, 34730589, 34579516, 35549651, 35704972, 34966065, 35275725, 35414537, 36686981, 36131889, 35887289, 35959094, 36381837, 36444560, 36904773, 36568511, 36818058, 36877470, 36956952, 37145060, 37378040, 37441854, 37463551, 37519834, 37622719, 38654173, 37862131, 38219391, 38083729, 38243471, 38364897, 38676524, 38526921, 35082296;   REF 89-6798: Lot numbers: 35705131, 35428533, 35705131, 35240186, 35428533, 35859085, 37195251, 37774798;   REF 89-6799: Lot numbers: 33605971, 35740658, 35705140, 35481730, 36189861, 36263371, 36337617, 33605971, 34581851, 35740658, 35481730, 36189861, 36263371, 36462565, 37146791, 36906699;  REF 89-6855: Lot numbers: 33531553, 33669421, 34506237, 35516331, 35093163, 34928253, 35949662, 36476174, 37391017, 37776726, 38745104, 38496419;  REF 89-7017: Lot numbers: 35243125, 34671478, 36191751, 37196908, 37651026, 37865391, 38148043, 38780840;  REF 89-7018: Lot numbers: 35240805, 33530201, 33593906, 33801146, 33883727, 34733211, 35515258, 35091918, 35948627, 35781417, 35948627, 36392659, 36190230, 36571702, 37147111, 36958536, 37412877, 37323604, 37775432, 37949228, 38132341, 38244924, 38495900, 38630876;   REF 89-7020: Lot numbers: 33670511, 34735953, 35243150, 35732210, 35243150, 36052953, 36575295, 36910049, 36960214, 37333280, 37777593, 37950085, 38133386, 38269398, 38344028, 38631887;   REF 89-7022: Lot numbers: 37011416, 33802886, 35242392, 35657467, 37011416, 36191312, 37333124, 38133036, 38872699, 38631588;   REF 89-7025: Lot numbers: 33532548, 38031339, 33803521, 34671494, 35658216, 35732201, 35517157, 35517165, 35243141, 35339881, 34959164, 36575287, 36664079, 36052945, 36317237, 36960193, 37196916, 37454225, 37651034, 37391623, 37651042, 37865403, 37974141, 38166807, 38229898, 38344010, 38496751, 38745391;   REF 89-7026: Lot numbers: 35881135, 34442368, 34504469, 35781425, 34957329, 35240821, 35515266, 35781425, 33667872, 35396279, 35781425, 35604971, 36051133, 36190248, 36315039, 36474849, 36571729, 36571745, 36811112, 36737231, 37010464, 37432966, 37464651, 37648716, 37863969, 37973885, 38178402, 38229450, 38030811, 38342743, 38456046, 38630884, 38779638, 38495918;   REF 89-7028: Lot numbers: 33597202, 33887613, 34587364, 34392621, 34882101, 34587364, 35094431, 35517350, 35782920, 36575498, 36910250, 37197054, 38521493, 37651350, 37777753, 37992015, 38160595, 38463799, 38246031;   REF 89-7031: Lot numbers: 33530243, 34442448, 34733270, 34819065, 34957353, 35038990, 35240881, 35240899, 35515311, 35730071, 35530440, 35240899, 34957353, 35948694, 36051192, 36133981, 36051192, 36133981, 36392683, 36445431, 36571948, 36571921, 36603401, 36811155, 37010499, 37464677, 37571421, 37195657, 37323655, 37812416, 37775521, 37863985, 37991426, 38193944, 38132375, 38244983, 38342778, 38456089, 38495926, 38630921;   REF 89-7058: Lot numbers: 34505971, 34928077, 37021569;  REF 89-7061: Lot numbers: 37264878, 33667469, 34925888, 34441605, 35091432, 35514845, 35948248, 36314423, 36570662, 36050771, 37648231, 38630673, 37264878, 37863723, 38274120, 33667469, 33593332;   REF 89-7062: Lot numbers: 33746239, 34507660, 34630991, 35782807, 35398434, 35782807, 36394443, 37391615, 38573082, 37741515, 37791344, 37848494, 38496742, 33746239;   REF 89-7067: Lot numbers: 33669114, 34820331, 35397247, 36051889, 36662911, 37453628, 37864671, 38343252, 33669114;   REF 89-7068: Lot numbers: 34709085, 34506173, 33885693, 35026340, 34506173, 35026340, 35242000, 35782321, 35484332, 35516314, 35093112, 35168284, 35278221, 35397482, 34958217, 35960520, 35894374, 36316218, 36931501, 36573767, 36908766, 37453741, 37477460, 38677771, 37390946, 37649971, 37813128, 37905129, 37991805, 38195317, 38245572, 38132893, 38343341, 38727993, 38520600, 33885693   REF 89-7075: Lot numbers: 33486924, 34735700, 35027334, 35331352, 36191574, 36394283, 36676248, 36959977   REF 89-7076: Lot numbers: 33544848, 33615677, 33781325, 33870619, 34486942, 34351773, 34868772, 35791949, 35801895, 35513201, 35602538, 35751517, 35791949, 34966129, 35501809, 36650961, 36244285, 35928925, 36068437, 36327013, 37057051, 36904837, 36568626, 36603217, 36619551, 36734971, 37476336, 37810832, 37312374, 37948680, 38147833, 38083770, 38243526, 38341687   REF 89-7105: Lot numbers: 37245811, 33530032, 33742502, 34732904, 34874005, 34560428, 35781193, 35515055, 35240565, 35329818, 33883330, 36675456, 36016493, 36050940, 36314829, 36737071, 36811016, 37010384, 36687158, 37400497, 37464520, 37648468, 37648476, 38519676, 37389911, 37824020, 37874537, 37775141, 37991389, 38090873, 38263412, 38365064, 38689499, 34560428   REF 89-7114: Lot numbers: 33486705, 33691266, 33547782, 33802894, 34697328, 34391652, 34391644, 34939577, 34697328, 34670715, 35657475, 35606897, 35731532, 35026825, 35026833, 35093497, 35484914, 35397853, 35484914, 35846321, 35894631, 36052363, 36135530, 36316672, 36328121, 37148412, 36909312, 36476537, 36574305, 36812297, 36663463, 37011424, 37148421, 37453919, 37465346, 35606897, 37650331, 37777041, 37813275, 37949800, 38185371, 38031224, 38133044, 38220316, 38274883, 38245759, 38745227, 38830747, 38520968, 38520976, 38697801;   REF 89-7115: Lot numbers: 33546641, 35396092, 34733026, 35396092, 35781257, 36675472, 36288632, 37076404, 36571260, 36958464, 36811075, 37147065, 37195526, 37323461, 37824038, 37775213, 37949156, 38219956, 38132279, 38342655, 38446770, 38744646, 38495854, 38630788;   REF 89-7116: Lot Numbers: 34507723, 34671523, 33887322, 34959199, 35094262, 34671523, 34959199, 35782823, 35517190, 35530503, 34959199, 35243176, 35339901, 35517190, 36328340, 36052988, 36191785, 36317288, 36019150, 36394478, 36575332, 36664116, 36960222, 37454233, 37651085, 37413044, 37777614, 37813574, 37324800, 37950093, 38031355, 38178568, 38344044, 38412545, 38496769, 38245960, 38745403, 38831133, 38631908, 33887322, 36191785, 34507723, 35782823;   REF 89-7118: Lot numbers: 34818791, 35655429, 35705166, 35396084, 35329869, 36050991, 36571243, 36958456, 38630770, 37648548, 37928911, 38132261, 38711086;   REF 89-7189: Lot numbers: 37266363, 35658232, 33803547, 34445235, 33887314, 34536479, 35517173, 35732236, 34929707, 35094254, 35243168, 34929707, 36052961, 36575316, 36664108, 35782815, 36052961, 36317253, 36910057, 37021753, 37465573, 37266363, 37391631, 37777606, 37865411, 38196230, 38031347, 38344036, 38631895, 38521389, 33548136, 33803547;    REF 89-7191: Lot numbers: 35657441, 33886291, 34506721, 35657441, 35731508, 35026796, 35331037, 35416381, 36631576, 36052339, 36316664, 36574276, 36631576, 36909267, 37453901, 37650306, 38520950, 37324439, 37777032, 37949789, 38085441, 38274867, 38745201, 33474982, 33547758, 33802860, 33886291;   REF 89-7281: Lot numbers: 33881297, 33360521, 33881297, 33903100, 34376137, 34451985, 34923962, 35513210, 35414596, 36131918, 36444607, 36630274, 36818111, 37217983, 38273291, 38494915;   REF 89-7301: Lot numbers: 34507766, 35860211, 35243213, 36053024, 37148914, 37865438, 38042901, 38275077;   REF 89-7343: Lot numbers: 33597093, 33618675, 33803694, 33860672, 34685394, 34822475, 34671662, 35658398, 35658401, 35027756, 35094385, 35485933, 35398522, 35846743, 35846751, 35846760, 35860262, 35950604, 35992724, 37011803, 36317421, 36317430, 36664167, 37651288, 37699071, 37777729, 37915693, 38042927, 38133431, 38344095, 38496785, 38521469, 38745471, 37699071;   REF 89-7390: Lot numbers: 33886186, 35606707, 34958479, 36052283, 37219321, 37465291, 38412262;   REF 89-7391: Lot numbers: 34670571, 35093340, 38830641, 35894542, 37864996, 38038397, 38343480, 38830641;   REF 89-7398: Lot numbers: 33399257, 33746191, 34586951, 34822205, 34959148, 34507635, 35732172, 35331547, 36019088, 36664044, 35895158, 36317202, 36575252, 36881541, 37011731, 37443825, 37266339, 37333255, 37651000, 37813566, 37777551, 38412529, 38756794, 38521371, 38654747;   REF 89-7401: Lot numbers: 34958946, 33817682, 34958946, 35398223, 36317042, 36739325, 38573074, 37865315, 38133327;   REF 89-7550: Lot numbers: 33486596, 33802579, 34958292, 36052152, 37021622, 37453791, 37650058, 38148001, 38520722;   REF 89-7602: Lot numbers: 35399146, 34741481, 34445868, 34736964, 33888106, 35517931, 34959666, 35399146, 35847421, 36317982, 36740318, 37391990, 37778289, 38185557, 38807432, 38497075, 33888106;   REF 89-7620: Lot numbers: 36960724, 34930476, 35399200, 36136997, 36813265, 36576394, 37454639, 38185565, 36960724, 34930476, 35399200, 36136997, 36813265, 36576394, 37454639, 38185565;   REF 89-7736: Lot numbers: 34737916, 35544067, 36318846;  REF 89-7737: Lot numbers: 35488165, 35609561, 37198284, 37867071;  REF 89-7918: Lot numbers: 34931962, 36912600, 36742399, 38086786, 37867901, 38008059, 33619459, 36087056, 33478676, 34354350, 34885759, 34631281, 35610423, 36244841, 36087056, 36124961, 36319531, 37151460, 36912600, 36742399, 36666269, 37653591, 38576443, 37700019, 37867901, 38008059, 38086786, 38142768, 38345354, 38447385, 38498191, 38746254, 38781965, 33478676, 33619459, 34354350, 34561009, 34631281;   REF 89-7924: Lot numbers: 37267948, 34673772, 35784829, 35553596, 35400549, 35245340, 36912731, 36545184, 36555340, 36580406, 36742452, 36814680, 37079373, 37151507, 37267930, 38465065, 38807820, 38498211, 38553399, 38633022, 38690078;   REF 89-7990: Lot numbers: 34817916, 34503271, 34817916, 34503271, 36810460, 37010026, 37432843,  37905031, 38030598, 37323111;   REF 89-7991: Lot numbers: 33471301, 33800557, 34817924, 35481326, 35266423, 35947974, 37010034, 36391971, 36810478, 37323129, 37838683, 37774579, 38132009, 38677236;   REF 89-8004: Lot numbers: 33546085, 34487531, 34749440, 34388947, 34872253, 35740623, 35740631, 35654776, 35072629, 35184292, 35240004, 35395356, 35947966, 35991764, 36661636, 36133139, 36314044, 36418564, 36906373, 37076033, 37195075, 37452810, 37570269, 37264704, 37273432, 37400251, 37838675, 37973691, 38084588, 38131997, 38244553, 38273987, 38441055, 38495643, 38519318, 38727281, 38779259;   REF 89-8010: Lot numbers: 34429761, 34366351, 36958051, 37146572, 37570285, 38244570, 38519326;   REF 89-8191: Lot numbers: 35867894, 35948723, 35887393, 36392712, 38371739;  REF 89-8198: Lot number 33546843;   REF 89-8249: Lot numbers: 35396578, 38342815, 35396578, 35388404, 38342815, 38446809, 38744742;   REF 89-8261: Lot numbers: 34785352, 35605237;   REF 89-8273: Lot numbers: 34733464, 34442544, 34733464, 36650443, 36907552, 37864136, 33667995, 34733464, 34390107;   REF 89-8308: Lot numbers: 35188293, 36315354, 34875551, 35188293, 36315354, 36675683, 38274429;  REF 89-8309: Lot numbers: 36811251, 37218855, 33801541, 34875518, 36811251, 37127427, 37218855, 37265395;  REF 89-8310: Lot numbers: 35893718, 36572545, 33500968, 34875315, 35837345, 36134246, 35893718, 36572545, 37521820, 37265379, 38006281;   REF 89-8311: Lot numbers: 33501098, 37928996, 38229548, 37195761, 37176780, 33501098, 37928996, 37195761, 38229548, 38496072;   REF 89-8372: Lot numbers: 33870900, 33870918, 34583419, 35039108, 36552368, 36717484, 37453281, 38496081, 33870900;  REF 89-8379: Lot numbers: 37195809, 37195809, 38245185;  REF 89-8394: Lot numbers: 34587874, 34736649, 36317675, 36420867;   REF 89-8407: Lot numbers: 34736462, 34952499, 35847017, 36192075, 36910381, 38185442, 38496873, 34587671;   REF 89-8409: Lot numbers: 34587698, 34792561, 34952528, 35950719, 35847033;  REF 89-8416: Lot numbers: 37777981, 37848700, 37791483, 38275173;  REF 89-8444: Lot numbers: 35398725, 35658566, 36053227, 36910348, 36881815, 37149175, 36724545, 37401051, 37454401, 38654771, 37777892, 38091139, 38105393, 37865569, 38091139, 38229986, 38263711, 38344239, 38745534, 38521573, 38553250, 37929243, 38553250;  REF 89-8445: Lot numbers: 35398741, 35658582, 37077757, 36317616, 36349001, 36881823, 36575746, 36664301, 37465653, 37651552, 37266507, 37391771, 37661128, 37937534, 38006643, 38133538, 38344255, 37937534, 37465653;   REF 89-8464: Lot numbers: 37929286, 37929286, 38160616, 37791491, 38073416, 38288433;  REF 89-8465: Lot numbers: 35751832, 35950794, 36019512, 36071100, 35895650, 36337852, 36739974, 37245976, 37454444, 38344301;  REF 89-8489: Lot number 38246268;  REF 89-8499: Lot numbers: 38246188, 36153447, 36420816, 36812959, 37077802, 36739860, 37324981, 37266531, 38085679, 38142493, 38185451, 38246188;   REF 89-8505: Lot numbers: 36291882, 36421333, 38085901;  REF 89-8547: Lot numbers: 36960986, 36987610;  REF 89-8548: Lot numbers: 36960978, 36987599;  REF 89-8549: Lot Numbers: 36987687, 36961129;  REF 89-8550: Lot number 36987581;  REF 89-8568: Lot numbers: 38497358, 37150088, 37197871, 38497358;  REF 89-8652: Lot numbers: 38007195, 38086090;  REF 89-8660: Lot number 38371982;  REF 89-8664: Lot number 38148094;  REF 89-8666: Lot numbers: 38166604, 38245062, 38256597;  REF 89-8673: Lot number 38590131;  REF 94-0245: Lot numbers: 33530841, 34505269, 33397294, 34390414, 33801955, 34390414, 34505269, 34584075, 35605632, 35483583, 35189472, 35025726, 35605632, 35949179, 36289213, 36811438, 36419591, 36540156, 37010755, 37195972, 37477187, 37522259, 37572192, 37323971, 37824206, 37864460, 38006387, 38132631, 38317417, 38317425, 38343068, 38727791, 38496224;   REF 94-0266: Lot numbers: 33534931, 33805551, 35489408, 34960595, 34960595, 37466621, 37506072, 37839248, 38498131, 38729876;  REF 94-0277: Lot numbers: 35030349, 36193238, 37839256, 38573234;  REF 94-0280: Lot numbers: 36620720, 38807782

General and Plastic Surgery Devices

2

No

Worldwide Distribution: US (nationwide) and country of Guatemala.

Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: || ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXTREMITY TRAY, REF 89-3609; BASIC TRAY, REF 89-3610; HAND TRAY, REF 89-3611; NEURO SPINE TRAY, REF 89-3808; NEURO CRANIOTOMY TRAY, REF 89-3809; BASIC SET UP TRAY, REF 89-4137; BASIC PACK, REF 89-4798; SJCHS EXTREMITY TRAY, REF 89-4832; TOTAL KNEE TRAY PGYBK, REF 89-4902; ORTHO SPINE TRAY, REF 89-4935; MAJOR EXTREMITY PACK, REF 89-5057; STANDARD LAP CHOLE PACK, REF 89-5059; UROLOGY CYSTO PACK, REF 89-5246; LAPAROSCOPIC CHOLE PACK, REF 89-5259; FACELIFT & EYELID PACK, REF 89-5609; FACELIFT PACK, REF 89-5611; LAPAROSCOPY PACK, REF 89-5978; HYSTEREOSCOPY TRAY, REF 89-5979; CABG PACK PGYBK A & B, REF 89-5985; OPHTHALMOLOGY PACK PGYBK, REF 89-6263; VASCULAR DRAPE PACK, REF 89-6264; HEART PACK PGYBK, REF 89-6341; SHOULDER PACK, REF 89-6354; MINOR CUSTOM PACK, REF 89-6374; CATARACT PACK PGYBK, REF 89-6377; SURGI-START KIT, REF 89-6378; PACEMAKER PACK, REF 89-6396; GENERAL LAPAROSCOPIC PACK, REF 89-6409; OPEN HEART PROCEDURE PACK TOTAL, REF 89-6508; TOTAL HIP PACK A&B;, REF 89-6798; KNEE PACK A&B;, REF 89-6799; MAIN OH SUPPLY A&B; PACK, REF 89-6855; CRANIOTOMY PACK, REF 89-7017; PACEMAKER PACK, REF 89-7018; GYN MINOR PACK, REF 89-7020; ENT MAJOR PACK, REF 89-7022; GENERAL MAJOR PACK, REF 89-7025; GENERAL MINOR PACK, REF 89-7026; PV PACK, REF 89-7028; GENERAL LAPAROSCOPY PACK, REF 89-7031; CRANIOTOMY PACK, REF 89-7058; LAPAROSCOPY PACK-LF, REF 89-7061; HEAD & NECK PACK, REF 89-7062; VAGINAL HYSTERECTOMY PACK-LF, REF 89-7067; C-SECTION PACK-LF, REF 89-7068; GYN LAPAROSCOPY PACK, REF 89-7075; OPEN HEART PACK, REF 89-7076; C-SECTION PACK, REF 89-7105; TOTAL KNEE PACK, REF 89-7114; ARTHROSCOPY ALL PACK, REF 89-7115; GENERIC ORTHO PACK, REF 89-7116; MINOR EENT PACK, REF 89-7118; COMPANION PACK, REF 89-7189; ENDO VASCULAR PACK, REF 89-7191; OPEN HEART BASIC PACK, REF 89-7281; CUSTOM ER HAND PACK, REF 89-7301; C-SECTION PACK, REF 89-7343; MINOR PACK-LF, REF 89-7390; EXTREMITY PACK, REF 89-7391; ANGIOGRAPHY PACK, REF 89-7398; ANGIOGRAPHY DRAPE PACK PEDI, REF 89-7401; C-SECTION PACK, REF 89-7550; LAMINECTOMY PACK, REF 89-7602; LAPAROSCOPY GEN/UROLOGY PACK, REF 89-7620; LAP CHOLE / APPY TRAY, REF 89-7736; BREAST/TUMMY PACK, REF 89-7737; BASIC PACK, REF 89-7918; LAP CHOLE PACK, REF 89-7924; ROBOTIC SUPPLY URO PACK, REF 89-7990; ROBOTIC SUPPLY GYN PACK, REF 89-7991; SET UP PACK, REF 89-8004; TRAUMA PACK, REF 89-8010; PACEMAKER PACK, REF 89-8191; E HAND PACK, REF 89-8198; NEUROSURGERY PACK, REF 89-8249; SURGERY PACK, REF 89-8261; EYE PACK, REF 89-8273; KNEE PACK, REF 89-8308; SHOULDER PACK, REF 89-8309; HAND PACK, REF 89-8310; PERI/GYN PACK, REF 89-8311; NEURO PACK, REF 89-8372; PODIATRY PACK, REF 89-8379; C-SECTION PACK, REF 89-8394; GENERAL SURGERY PACK, REF 89-8407; GENERAL MALE PACK, REF 89-8409; HAND PACK, REF 89-8416; TOTAL HIP PACK PGYBK, REF 89-8444; TOTAL KNEE PACK PGYBK, REF 89-8445; SURGICAL PODIATRY PACK, REF 89-8464; CATH LAB PACEMAKER PACK, REF 89-8465; BREAST PACK, REF 89-8489; HEAD/NECK PACK, REF 89-8499; EXTREMITY PACK, REF 89-8505; KNEE ARTHROSCOPY PACK, REF 89-8547; SHOULDER ARTHROSCOPY PACK, REF 89-8548; UROLOGY PACK, REF 89-8549; ENT PACK, REF 89-8550; LAMINECTOMY PACK, REF 89-8568; ANT CERV FUSION PACK, REF 89-8652; ENDO BROW FACELIFT PACK, REF 89-8660; PODIATRY PACK, REF 89-8664; GENERAL SURGERY PACK REF 89-8666; Basic Set Up Pack, REF 89-8673; C-SECTION TRAY PGYBK, REF 94-0245; UNIVERSAL BREAST TRAY, REF 94-0266; DR. HAND TRAY, REF 94-0277; FEM-POP TRAY, REF 94-0280 || Usage: general surgical

RES 47-763.02, Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527  RES 47-773, Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745  RES 50-12437.08, Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765  RES 89-6818.01, Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296  RES 89-5649.01, Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531   RES 32-1695, Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758  RES 32-351, Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430  RES 89-6752.01, Lot Numbers: 20835339, 21511803, 23485821  RES 89-7212.01, Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321

General and Plastic Surgery Devices

1

No

Nationwide Distribution--including the states of CA, FL,GA, HI, IL, IN, LA, MA, MO, MS, NY, PA, and RI.

DeRoyal (R) Incision and Drainage Tray, RES 47-763.02, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20641391, 21092240, 21950988, 22594153, 22739623, 22773346, 23068497, 23098901, 23435082, 24203902, 24725655, 24781729, 24901874, 25403527 || DeRoyal (R) Incision and Drainage Tray, RES 47-773, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20432290, 20605752, 20922248, 21092178, 22615161, 23231338, 23567595, 24526171, 24781745 || DeRoyal (R) Incision and Drainage Tray, OCEAN SPRINGS HOSP, RES 50-12437.08, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22871229, 23187891, 23282362, 23335049, 23693022, 24004508, 24289321, 24599046, 24853850, 25159510, 25609040, 20675048, 20886013, 21316397, 21529982, 21861715, 22203984, 22412903, 22729708, 22799765 || DeRoyal (R) Incision and Drainage Tray, ST JOSEPHS HOSPITAL, RES 89-6818.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 23606275, 23941604, 24336115, 24867670, 25220026, 25324301, 25814617, 21364022, 21372541, 21420961, 21469650, 21527602, 21641296 || DeRoyal (R) Universal Insertion Tray, RES 89-5649.01, ST FRANCIS MED CAPE GIRARDEAU, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22981727, 23234934, 21320071, 21374634, 21651531, 21817255, 22019861, 22187911, 22588503, 21651531 || DeRoyal (R) St. Suture Removal Kit, RES 32-1695, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic || Lot Numbers: 20170218, 21096486, 21114411, 21242931, 21331394, 21344427, 21381711, 23683529, 23767212, 23883758 || DeRoyal (R) Stainless Suture Removal Set, RES 32-351, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA, made in Dominican Republic || Lot Numbers: 20188629, 20738627, 20838062, 21114437, 21410754, 21667171, 21790558, 22052557, 22389467, 22572739, 22865427, 23169950, 23452384, 23627906, 23883820, 24255913, 24408502, 24957430 || DeRoyal (R) CRICOTHYREOTOMY AMBULANCE KIT, WISHARD MEMORIAL HOSPITAL, RES 89-6752.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 20835339, 21511803, 23485821 || DeRoyal (R) DR MATA'S PLASTIC PACK, OUR LADY OF LOURDES, RES 89-7212.01, Rx Only, STERILE EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Numbers: 22408453, 22653627, 22718814, 22777961, 23218782, 23942181, 24285119, 24571254, 24597462, 25414921, 25527677, 25646027, 25683611, 25744313, 25744321 || Custom Surgical kits.

The lot affected was manufactured on production work order 14097259

Descriptor- lntraoperative Procedure Bag

Lot Numbers: 32901129, 32980912, 33015541, 33024746, 33105239

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Numbers: 32871775, 32980891, 33132755, 33141184, 33217572, 33329945

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Numbers: 32871821, 32976471, 33105247

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Numbers: 32901145, 33063999, 3132641, 3217556, 33276468, 33369411, 33412431, 33415413

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Number: 32871812

Physical Medicine Devices

2

No

Nationwide Distribution.

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. || Physical Therapy.

Lot Number 40004006

General and Plastic Surgery Devices

2

No

Distributed in LA and TN.

DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,

Lot Number 32794811

Ophthalmic Devices

2

No

Nationwide Distribution

DeRoyal (R) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA || cleaning of fluids from surgical site in or near the eye

Lot Number 44210051

General and Plastic Surgery Devices

2

No

Honduras, Belgium, and The Netherlands

DeRoyal(R) SURGI MATE(R) Electrosurgical Pencil, Button Switch, with 15 ft (4.6 m) Cord and Holster, REF 88-001502 || Product Usage: general surgical

1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515

General and Plastic Surgery Devices

2

No

US Nationwide Distribution

DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only || Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.

a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132

General and Plastic Surgery Devices

2

No

US Nationwide distribution in the states of GA, IN, FL, and PA

DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: || a) Incision and Drainage Tray, REF 47-763.04 || b) Incision and Drainage Tray, REF 47-763.06 || c) Incision and Drainage Tray, REF 47-763.07 || d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 || e) Incision and Drainage Tray, REF 89-6818.02 || f) Plastic Pack, REF 89-7212.04 || g) Plastic Pack, REF 89-7212.05 || Product Usage: || Custom surgical and procedural kits

Lot Number 21989639

Obstetrical and Gynecological Devices

2

No

USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.

DeRoyal (R) ST. Circumcision Clamp, REF 32-1622, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Circumcision Clamp

Lot Numbers: 20854003, 22892644, and 20012949

Obstetrical and Gynecological Devices

2

No

USA (nationwide) including the states of AR, AZ, FL, GA, LA, MI, NJ, NM, and OH.

Circumcision trays and packs listed as follows: || (1) DeRoyal (R) ST. Circumcision Tray, REF 50-5613, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Made in Dominican Republic || Lot Numbers: 20854003, 22892644 || (2) DeRoyal (R) ST. Circumcision PACK 1.3 CLAMP CLAMPMEMORIAL HEALTH, MEMORIAL HOSP TAL WEST, REF 89-5699, 1 Per Pack, Rx Only STERILE EO, Distributed by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA; Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA || Lot Number 20012949 || Circumcision Clamp

Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541

General and Plastic Surgery Devices

2

No

Distributed in the states of MI, GA, OH, IL, MO, and IN.

DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala

Lot Numbers: 27453624, 28013145, 28103757, 28117631, 28158774, 28215628, 28230174, 28252349, 28299104, 28317940, 28326230, 28405309, 28455138, 28486735, 28506265, 28568132, 28609969, 28631875, 28736343, 28793541, 28854180, 28908555 28961727, 29015839, 29083612, 29169512, 29214272, 29271744, 29339294, 29412771, 29522363, 29722357, 29754033, 29799485, 29850754, 30021523, 30092305, 30092604, 30134253, 30179216, 30728465, 30819738, 30957330, 31010691, 31015441, 31103782, 31296166, 31402993, 31469522, 31469709, 31576221, 31601554, 31671907, 32333862, 32335500, 32355746,  32550841, 32618796, 32689527, 32728688, 32764718, 32817091, 32834780, 32869000, 32933711, 32980699, 33011814, 33064334, 33087341, 33087350, 33197866, 33682175, 33736364, 33737623, 33783267, 34405461, 34699585, 34762863, 34768309, 34913043, 34939286, 34963841, 35170632, 35270238, 35270529, 35327337, 35544446, 35554708, 35580025, 35598516, 35710820, 35798577, 35828254, 35828449, 35870920, 35898261, 35952677, 36024274, 36081851, 36142094, 36142174, 36200101, 36273801, 36283541, 36309333 36341317, 36530441, 36605837, 36679545, 36953532, 37017210, 37079672,  37079787, 37083356, 37155305, 37189791, 37268916, 37331858, 37395771, 37396029, 37513643, 37654374, 38032551, 38088191, 38180246, 38235278, 38392951, 38457153, 38525030, 38551001, 38623300, 38625866, 38747370, 38788673, 38832507, 38832603, 38997758, 39013351, 39054022, 39076627, 39148951, 39579507, 39661447, 39706174, 39762352, 39812284, 39868780, 40017667, 40080121, 40149328, 40152447, 40264393, 40321968, 40322021, 40342363, 40380888, 40453186, 40453338, 40541549, 40607430, 40890010, 41161601, 41257048, 41263018, 41356935, 41411287, 41467416, 41544848,  41561980, 41601056, 41665404, 41740013, 41755485, 41755506, 42077436, 42077461, 42200721, 42332644, 42332661, 42406164, 42523723, 42523782, 42550246, 43479550, 43493941, 43531688, 43710715

General and Plastic Surgery Devices

2

No

MS & LA

DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED WITHIN.

Lot Numbers: 30674381, 30721925, 30733281, 31029711, 31442590, 31649363

General and Plastic Surgery Devices

2

No

Distributed in the states of MI, GA, OH, IL, MO, and IN.

DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.

Lot number 13063705

General and Plastic Surgery Devices

1

No

LA & KY

DeRoyal Lap Chole Tray, REF 89-4823.06, Rx, Sterile EO. (custom surgical kit)

REF 50-11656.02: Lot Number 19321517

General and Plastic Surgery Devices

1

No

Nationwide Distribution

Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO HOSP, REF 50-11656.02, Rx Only, STERILE EO, Manufactured by: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA.

lot numbers 1143442 and 1161762

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.

DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 || Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others

REF 89-7639.01 - Lot Number 24579045  REF 89-7639.01 - Lot Number 24664258  REF 89-7639.02 - Lot Numbers: 24828048, 25598985, 25359212, 25399676

General and Plastic Surgery Devices

1

No

(USA) including Indiana

Custom surgical kits: || DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 || surgical kits