Lot Number: 1179107

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - USA (nationwide) and France.

Laparoscope, general; plastic surgery || Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.

Model Numbers C4130 and C4140.  MODEL NUMBERS    C4130- 5mm x 35cm Epix/Direct Drive Laparoscopic Grasper  LOT NUMBERS  1145332, 1145943, 1145944, 1145945, 1145992, 1145993, 1145994, 1146371, 1147900, 1147901, 1147955, 1148172, 1148173, 1148174, 1148180, 1148181, 1148184, 1148190, 1148191, 1148192, 1148194, 1148201, 1148203, 1148677, 1148765, 1148766, 1148767, 1148835, 1149040, 1149041, 1149690, 1149757, 1150168, 1150169, 1150170, 1150490, 1150634, 1151246, 1151247, 1151248, 1152274, 1152728, 1153332, 1154394, 1154637,  1155135, 1155473, 1155948, 1156004, 1156010, 1156011, 1156012, 1156270, 1156360, 1156452, 1156577, 1156857, 1157218, 1157679, 1157950, 1157951, 1157952, 1157953, 1157954, 1158052, 1158131, 1158216, 1158217, 1158425, 1159491, 1160167, 1161136, 1161137, 1161398, 1161638, 1162112, 1162503, 1162504, 1162588, 1163399, 1163558, 1163559, 1163575, 1164580, 1164581, 1164582, 1164583, 1168124, 1168637, 1168638, 1169117, 1171168, 1171631, 1172170, 1172668, 1173153, 1174995, 1174996, 1176616, 1177407, 1177408, 1178109, 1180295, 1181554, 1182940, 1183774, 1184416, 1184959, 1187241, 1188110, 1188745, 1189773, 1191368, 1191809.  C4140- 5mm x 45cm Epix/Direct Drive Laparoscopic  Grasper  1145559, 1147851, 1147852, 1147960, 1148210, 1148211, 1149038, 1149039, 1149689, 1149936, 1150488, 1150489, 1151249, 1152594, 1153330, 1155645, 1157217, 1157949, 1158644, 1160033, 1160170, 1162111, 1167871, 1169855, 1171497, 1172009, 1173587, 1174121, 1177578, 1179347, 1180753, 1181346, 1182924, 1183769, 1184961, 1188111, 1189182  Various Kits Containing Either C4130 or C4140 1148079, 1148139, 1148145, 1148250, 1148514, 1148770, 1148780, 1149100, 1149605, 1150455, 1151831, 1153074, 1153702, 1154931, 1154997, 1155332, 1156581, 1156812, 1157090, 1158535, 1160152, 1160227, 1160388, 1161766, 1162189, 1162343, 1163348, 1163881, 1164590, 1164796, 1164831, 1165443, 1166520, 1168227, 1169190, 1169456, 1169620, 1169772, 1170151, 1170378, 1171280, 1171878, 1171879, 1172330, 1173319, 1173903, 1174093, 1175987, 1175991, 1176171, 1178210, 1178498, 1178581, 1179376, 1182679, 1182972, 1183303, 1184673, 1185599, 1185762, 1186257, 1186868, 1187082, 1188827, 1189581, 1190574, 1191055, 1193112, 1193147, 1193648, 1193688, 1194964,  1194965

Obstetrical and Gynecological Devices

1

No

Worldwide Distribution: USA Nationwide and countries of: Argentina, Austria, Australia, Bahrain, Belgium, Canada, Chile, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Jordan, Kuwait, Malaysia, Lebanon, Lybia, Mexico, Netherlands, New Zealand, Pakistan, Peru, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, Spain, South Africa, Switzerland, Taiwan-Province of China,Turkey, United Arabs Emirates United Kingdom, Uruguay, and Venezula-Bolivarian Republic.

Applied Medicals Epix¿ and Direct Drive Laparoscopic Graspers, Model Numbers C4130 and C4140. || Used for grasping and manipulating tissue during general or laparoscopic surgery.

Model Number CD004. Lot Nubmers: 1161268, 1161269, 1164934, 1168358, 1168361, 1169317, 1169318, 1170694, 1170700, 1170701, 1171214, 1172482, 1172664, 1174287, 1174793, 1174857, 1175123, 1175280, 1175472, 1176555, 1177023, 1177871, 1179069, 1179392, 1179460, 1179775, 1179890, 1180291, 1180411, 1180576, 1181647, 1181648, 1181649, 1181939, 1182760, 1182934, 1183225, 1183823, 1183957, 1184273, 1184728, 1184915, 1184916, 1187779, 1188817, 1189117, 1189957, 1190294, 1190358, 1191208, 1192057, 1192969, 1193196, 1193661, 1194010, 1194666, 1194807, 1195518, 1195727, 1195997, 1197182, 1197404, 1197832, 1198055, 1198968, 1199899, 1200658, 1200828, 1200829, 1200830, 1201739, 1201740, 1201741, 1203154, 1204054.

General and Plastic Surgery Devices

2

No

Worldwide Distribution: US (nationwide) and countries of: Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, New Zealand, Netherlands, Norway, Peru, Poland, Portugal, Saudi Arabia, Singapore, Spain, South Africa, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Applied Medical's Inzii¿ 12/15mm Retrieval System. || Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

Model Number: C0R36, Lot Numbers:1084426 and 1085506.

General and Plastic Surgery Devices

2

No

Class II Recall - Worldwide -- United States, Australia, New Zealand, France, Canada, Norway and Great Britain.

Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. || Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery.

1084821, 1084822, 1084823, 1089653, 1090833, 1096177

General and Plastic Surgery Devices

2

No

Worldwide Distribution - Nationwide in the USA and to countries of: Australia, Austria, Belgium, Canada, Chile, Columbia, Cyprus, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, and Switzerland.

Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R39 || Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

1084813, 1084814, 1084820, 1089654, 1091175, 1090426

General and Plastic Surgery Devices

2

No

Worldwide Distribution - Nationwide in the USA and to countries of: Australia, Austria, Belgium, Canada, Chile, Columbia, Cyprus, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, and Switzerland.

Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R38 || Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

1077612, 1078134, 1079448, 1081556, 1082011, 1083371, 1084938, 1085509, 1087279, 1089638, 1088096, 1090841, 1091538, 1093144, 1097420

General and Plastic Surgery Devices

2

No

Worldwide Distribution - Nationwide in the USA and to countries of: Australia, Austria, Belgium, Canada, Chile, Columbia, Cyprus, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, and Switzerland.

Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R37 || Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

1077611, 1078133, 1079447, 1080157, 1080435, 1082010, 1084042, 1087280, 1087831, 1088565, 1089637, 1089939, 1089988, 1090427, 1091067, 1090849, 1091176, 1092599

General and Plastic Surgery Devices

2

No

Worldwide Distribution - Nationwide in the USA and to countries of: Australia, Austria, Belgium, Canada, Chile, Columbia, Cyprus, Denmark, Finland, France, Germany, Great Britain, Hong Kong, India, Ireland, Italy, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, and Switzerland.

Applied Medical 15x100 mm Kii Optical Access Systems, Non-Threaded 6/Box, Model C0R36 || Product Usage: Applied Medical's C0R36, C0R37, C0R38, and C0R39 trocars are diposable single-use devices indicated for use in general, abdominal, gynecological and thoraic minimally invasive surgeries. Trocars establish a path of entry through tissue planes and into internal spaces for purposes of inserting endoscopic instruments that are used to perform surgery on internal organs.

1115314, 1119397, 1122010, 1122067, 1127490, 1129502, 1130375

Cardiovascular Devices

2

No

Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.

Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 15/Bx || Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.

1112662,1115821,1121413,1122062, 1122163,1125949,1129996,1130225, 1131354

Cardiovascular Devices

2

No

Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.

Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx || Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.

1114700,1117956,1122073,1128221, 1130157,1133116

Cardiovascular Devices

2

No

Worldwide distribution: USA (nationwide) including states of: Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, and Michigan; and countries of: Japan, Israel, and Singapore.

Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx || Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The clamps are available in 33, 45, 61 and 86 mm jaw lengths and the inserts are designed to snap easily into the clamp jaws.

1112177, 1112935, 1123914, 1126274, 1132432, 1128149, 1129688, 1132432, 1133852, 1129688, 1133852, 1135372, 1136464, 1137996, 1139978, 1141874, 1144295, 1146403, 1125156, 1125279, 1126853, 1126853, 1130549, 1111831, 1111947, 1112024, 1125131, 1135284, 1139948, 1111842, 1138635, 1143347, 1111842, 1138635, 1143347, 1125499, 1132309, 1133063, 1134258, 1137548, 1138923, 1143888, 1146663, 1111843, 1130029, 1130029, 1139271, 1139365, 1145313, 1112273, 1124108, 1127084, 1131634, 1136135, 1127363, 1125662, 1125662, 1126390, 1127004, 1128850, 1130615, 1131158, 1136058, 1136556, 1139202, 1139316, 1139316, 1139316, 1135424, 1141142, 1146443, 1147253.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.

Direct Drive Grasper, VARIOUS KITS CONTAINING EITHER C4130 || OR C4140 || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.

C4140, 5MM X 45CM DIRECT DRIVE GRASPER 10/BX:  1109789, 1110338, 1120502, 1121622, 1122986, 1125449, 1126857, 1128330, 1128927, 1129474, 1130990, 1131764, 1132586, 1136813, 1137334, 1139969, 1141463, 1142396, 1143131.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.

Direct Drive Grasper, Model number C4140, 5MM X 45CM DIRECT DRIVE || GRASPER 10/BX || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.

C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX: 1109421, 1109787, 1110340, 1119363, 1120205, 1120207, 1121053, 1121057, 1121624, 1121756, 1122974, 1123411, 1123710, 1123872, 1124355, 1124556, 1124717, 1125445, 1125447, 1125710, 1125887, 1126120, 1127581, 1127583, 1128329, 1128334, 1128336, 1128434, 1129471, 1129473, 1130479, 1131482, 1131483, 1131484, 1131485, 1131486, 1132587, 1133099, 1134795, 1134796, 1134799, 1135529, 1135553, 1136810, 1136814, 1137509, 1137511, 1138374, 1138557, 1139245, 1139247, 1139968, 1141460, 1141461, 1141462, 1141857, 1141859, 1142395, 1142398, 1143129, 1143130, 1143133, 1143609, 1144837, 1144838, 1144840, 1144841.

General and Plastic Surgery Devices

2

No

Worldwide Distribution - USA (nationwide) including the state of Puerto Rico and the countries of: Australia, Bahrain, Canada, Chile, Colombia, Ecuador, Europe, India, Israel, Jordon, Kuwait, Lebanon, Libya, Malaysia, Mexico, Peru, Qatar, Singapore, , South Africa, South Korea, Saudi Arabia. Taiwan, Thailand, Turkey, and Venezuela.

Direct Drive Grasper, Model numbers C4130, 5MM X 35CM DIRECT DRIVE GRASPER 10/BX || Intended Usage: The grasper is indicated for grasping and manipulating tissue during general or laparoscopic surgery. The instrument is not intended for use when minimally invasive techniques are contraindicated. Complications which have been reported secondary to surgical grasping and manipulation include, but are not limited to: local trauma, injury, and tissue necrosis.

Model Numbers: Lot Numbers IRR-023-10F: 1158230. IRR-080-4F: 1156082, 1170185, 1164648. IRR-080-6F: 1158960.

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

Irrigation Catheters (Models IRR-XXX-XX): || Model Numbers & Description: || IRR-023-10F,CATHETER IRRIGATION 10F 23CM; || IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; || IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. || Irrigation Catheters are indicated for irrigation in the peripheral vascular system and biliary tree.

Model Numbers: Lot Numbers A4402: 1157054, 1163804, 1170473. A4403: 1157060, 1162689, 1166031, 1169109. A4404: 1160223, 1163803, 1166725, 1171181. A4405: 1155214, 1157053, 1161472, 1162967, 1164628, 1168912. A4406: 1155428, 1162945, 1167745, 1170042. A4407: 1154478, 1162866, 1168604. A4408: 1163626. A4F00: 1164152, 1164627, 1168666. A4F01: 1156256, 1160007, 1163628, 1168231. A4F02: 1156522, 1161792, 1170399. A4F03: 1155855, 1157052, 1161793, 1160310, 1159725, 1163215, 1163961, 1167855, 1169632, 1164626, 1165853. A4F04: 1155427, 1160221, 1161791, 1156935, 1171883, 1169729, 1167751, 1165778, 1163384, 1172598. A4F05: 1155854, 1154446, 1156936, 1155230, 1161471, 1160222, 1159414, 1161998, 1163216, 1163962, 1167440, 1166463, 1164625, 1165323, 1168911. A4F06: 1155856, 1154435, 1158624, 1161997, 1164149, 1165777, 1169013. A4F07: 1171170, 1156271, 1167414, 1164151. A4F08: 1168855, 1155648. CE0260ST: 1164307, 1168569. CE0280ST: 1164351. CE0340ST: 1164348. CE0380ST: 1164308, 1164337, 1166033, 1169029, 1166281, 1166032. CE0440ST: 1164336, 1168610. CE0480ST: 1164303, 1164302, 1164335, 1164304, 1166468, 1168605, 1166284, 1166283. CE0580ST: 1164345, 1164346, 1168613. CE0680ST: 1164330, 1166470. CE0780ST: 1164354. CE0340: 1166904. CE0380: 1164344. CE0440: 1164347, 1168609. CE0480: 1164343. CE0580: 1164349. CE0680: 1164353 CE0780: 1169926.

Cardiovascular Devices

2

No

Worldwide Distribution-USA (nationwide) and the countries of United Arab Emirates, Austria, Australia, Belgium, Canada, Germany, Ecuador, Estonia, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Italy, Republic of Korea, Libyan Arab Jamahiriya, Malaysia, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Taiwan, and South Africa.

Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): || Model Numbers & Description: || A4402, 3F-40CM, SYNTEL RT-EMB; || A4403, 3F-80CM, SYNTEL RT-EMB; || A4404, 4F-40CM, SYNTEL RT-EMB; || A4405, 4F-80CM, SYNTEL RT-EMB; || A4406, 5F-80CM, SYNTEL RT-EMB; || A4407, 6F-80CM, SYNTEL RT-EMB; || A4408, 7F-80CM, SYNTEL RT-EMB; || A4F00, 2F-60CM (PREM) SYNTEL CATHETER; || A4F01, 2F-80CM, (PREM) SYNTEL CATHETER; || A4F02, 3F-40CM, (PREM) SYNTEL CATHETER; || A4F03, 3F-80CM, (PREM) SYNTEL CATHETER; || A4F04, 4F-40CM, (PREM) SYNTEL CATHETER; || A4F05, 4F-80CM, (PREM) SYNTEL CATHETER; || A4F06, 5F-80CM, (PREM) SYNTEL CATHETER; || A4F07, 6F-80CM, (PREM) SYNTEL CATHETER; || A4F08, 7F-80CM, (PREM) SYNTEL CATHETER; || CE0260ST, L2F-60CM PREM SYNTEL CATH; || CE0280ST, L2F-80CM PREM SYNTEL CATH; || CE0340ST, 3F-40cm (PREM) SYNTEL CATHETER; || CE0380ST, 3F-80CM PREM SYNTEL CATH; || CE0440ST, 4F-40CM PREM SYNTEL CATH; || CE0480ST, 4F-80CM PREM SYNTEL CATH; || CE0580ST, 5F-80CM PREM SYNTEL CATH; || CE0680ST, 6F-80cm (PREM) SYNTEL CATHETER; || CE0780ST, 7F-80CM PREM SYNTEL CATH; || CE0340, 3F-40cm, SYNTEL RT-EMB; || CE0380, 3F-80cm, SYNTEL RT-EMB; || CE0440, 4F-40cm, SYNTEL RT-EMB; || CE0480, 4F-80cm, SYNTEL RT-EMB; || CE0580, 5F-80cm, SYNTEL RT-EMB; || CE0680, 6F-80cm, SYNTEL RT-EMB; || CE0780, 7F-80cm SYNTEL RT-EMB. || BARD Embolectomy Catheters are indicated for the removal of emboli and thrombi from the peripheral arterial system. These devices consist of a catheter body with a latex-free balloon on the distal end and an inflation hub on the proximal end.

Product/Kit Batch Numbers: 1059636, 1060354, 1061309, 1062314

General and Plastic Surgery Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled || (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

Product/Kit Batch Numbers: 1059718, 1060488, 1061516, 1062296, 1063810

General and Plastic Surgery Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.

Product/Kit Batch Numbers: 1057269, 1057814, 1058172, 1058834, 1059466, 1059823, 1060637, 1061254, 1062450, 1062867, 1063561, 1063797, 1064872

General and Plastic Surgery Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.

Product/Kit Batch Numbers: 1060178, 1056644, 1056045

Obstetrical and Gynecological Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Product/Kit Batch Number 1059804

Obstetrical and Gynecological Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

Product/Kit Batch Numbers: 1061115, 1058102, 1057096

Obstetrical and Gynecological Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)

General and Plastic Surgery Devices

2

No

US and worldwide: Australia, Finland, France, United Kingdom

Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and || Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.

Product/Kit Batch Numbers: 1061480, 1061127, 1060184, 1058796, 1058108, 1056578, 1056709, 1054094, 1054837

Obstetrical and Gynecological Devices

2

No

Nationwide and Canada distribution.

Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.

Model Number: EB040  Lot Numbers: 1243964, 1243975, 1244125  Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264

General and Plastic Surgery Devices

2

No

Worldwide Distribution - U.S Nationwide in the states of:FL, GA, NV. and countries of: France, Netherlands, Spain, and United Kingdom.

Voyant Open Fusion Device || Models: EB040 and EB040+ || Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue.