Integra Limited

Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.  Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580, 305000208008, 305000208510, 3050RY207892, 305000210060, 3050RX208008, 3050RX208510, 3050RX205976, 3050RX206178, 305000210563, 305000211723, 3050RX210060, 305000212616, 305000213007, 305000213191, 30500X210563, 3050RX207061, 305000214590, 3050RX205426, 30500X215502, 3050RX207062, 305000215531, 30500X216410, 3050RY199850, 305000216132, 30500X216627, 30500X217119, 3050RY217112, 305000216718, 3050RX217751, 3050RX217840, 3050RY217837, 305000217858, 30500X218369, 30500X218391, 30500X219054, 3050RY206178, 305000220708, 305000218578, 30500X220430, 305000219261, 30500X221221, 305000221226, 305000219989, 30500X222569, 305000221953, 305000221955, 30500X223153, 30500X223709, 305000223275, 305000223280, 305000222640, 30500X224142, 305000223867, 305000223866, 30500X224692, 305000224352, 305000224353, 30500X225386, 305000225045, 305000225044, 30500X225992, 305000225632, 305000225633, 30500X226540, 30500X227059, 305000226844, 305000226846, 305000226127, 30500X227564, 305000226836, 30500X227820, 305000227127, 305000227128, 30500X228194, 305000227790, 305000227789, 30500X228787, 305000228522, 305000228521, 305000228971, 305000228972, 30500X229560, 305000229328, 305000229329, 30500X229766, 30500X230087, 305000229825, 305000229826, 30500X230565, 305000230303, 305000230302, 30500X231053, 305000230780, 305000230781, 30500X231786, 305000231461, 305000231462, 30500X232331, 305000232098, 305000232099, 30500X232960, 305000232605, 305000232604, 305000233245, 305000233244, 305000233243, 305000233242, 305000233241, 305000233240, 30500X233415, 30500X234183, 305000233607, 305000233608, 30500X234806, 305000234303, 305000234304, 305000235022, 305000235017, 30500X235732, 305000235598, 30500X236328, 305000236105, 305000236104, 305000236655, 305000236653, 30500Y237087, 30500X237090, 305000237232, 30500X237761, 305000237824, 305000237825, 30500X238273, 305000238263, 305000238264, 30500X239095, 305000238818, 305000238819, 30500X239497, 30500X239748, 30500X239958, 30500X240334, 30500X240668, 30500X241368, 305000241516, 305000242236, 305000242792, 305000242795, 305000242796, 305000242794, 305000242793, 305000242791, 3050RY243869, 305000243251, 305000243882, 305000243881, 305000243888, 305000243889, 305000243883, 30500X244281, 30500X244880, 305000244513,30500X245306, 305000244481, 305000244480, 305000244934, 30500X245937, 30500X246067, 305000245408, 30500X246872, 305000245835, 30500X246951, 30500X247608, 305000246460, 30500X248284, 305000247007, 3050RX227127, 3050RX234303, 305000247717, 305000249072, 3050RX242794, 3050RX242793, 3050RX237825, 3050RX241516, 30500X249488, 305000248479, 30500X250423, 305000249743, 30500X250964, 305000250456, 30500X251060, 305000251055, 30500X251560, 30500X252133, 3050RY252136, 305000251453, 30500X252771, 305000252058, 3050RX244513, 305000252646, 305000253785, 30500X254929, 3050RY255145, 30500X255141, 305000254589, 305000255549, 305000255551, 305000255038, 30500X256614, 305000256192, 305000257281, 305000256709, 305000257280, 305000258048, 30500X259385, 305000258379, 305000258921, 305000258922, 30500X259557, 305000259431, 305000259432, 30500X260159, 305000259966, 305000259960, 305000260514, 305000260527, 30500Y261748, 3050RX253785, 305000261325, 305000261326, 305000261737, 305000261736, 3050RX256192, 30500X262441, 305000262328, 305000262327, 305000262978, 305000262977, 3050RY263508, 30500X263559, 305000263504, 305000264073, 305000264074, 305000264625, 305000264624, 3050RY265348, 30500X265422, 30500X265976, 3050RY265975, 305000265530, 305000265527, 30500X266142, 305000266134, 305000266135, 30500X266789, 305000267193, 305000267194, 3050RX261325, 30500X267468, 305000267421, 305000267422, 30500X267990, 305000267673, 305000267674, 305000268294, 305000268293, 305000266784, 305000268914, 305000268915, 3050RX261736, 3050RY269955, 30500X269963, 305000269220, 305000269221, 305000270081, 3050RY271045, 30500X271047, 305000271042, 305000271716, 305000271715, 30500X272367, 305000272273, 305000272274, 305000272852, 305000272851, 30500X274204, 305000273466, 305000273463, 305000274200, 305000274201, 30500X275297, 30500X275393, 305000274816, 30500X276594, 3050RX268914, 305000277761, 3050RY282196, 305000282304, 30500X282815, 3050RY283371, 3050RX283315, 3050RX283314    Catalog Number 110-4G: 3050RX195650, 3050RX198690, 3050RY193969, 3050RY197837, 3050RX199151, 3050RX199942, 3050RX201552, 3050RY185259, 3050RX200538, 305000206177, 3050RX200989, 305000206556, 305000206557, 3050RX200990, 3050RY199151, 3050RY199942, 305000207465, 3050RY200538, 3050RY200989, 305000208007, 3050RY200990, 3050RX207465, 3050RX206557, 3050RX206556, 305000209417, 305000209105, 3050RX208007, 305000210891, 305000211419, 3050RX206177, 30500X209105, 3050RX209417, 305000212298, 30500X210891, 305000213240, 305000214103, 30500X215501, 30500X215577, 3050RX202201, 305000215628, 3050RY195650, 3050RY198690, 30500X216621, 305000216246,3050RY217113, 30500X217118, 305000217140, 30500X217835, 3050RY217839, 305000217464, 30500X218393, 305000218009, 30500X219053, 305000218225, 305000219118, 30500X220001, 30500X220429, 305000219990, 30500X221225, 305000221227, 30500X222567, 305000222642, 305000223279, 30500X223707, 305000223868, 30500X224685, 305000224354, 30500X225383, 305000225046, 305000225634, 30500X226000, 30500X226541, 305000226731, 305000226869, 305000226867, 30500X227567, 305000227129, 30500X228784, 305000228523, 305000228973, 30500X229561, 305000229330, 30500X230084, 305000229827, 305000230304, 30500X231054,305000230782, 30500X231787, 305000231463, 30500X232333, 305000232101, 30500X232776, 305000232606, 30500X233419, 305000233246, 305000233609, 30500X234690, 30500X234807, 305000234306, 305000235566, 30500X236329, 30500Y237088, 30500X237767, 305000237233, 305000238820, 30500X239496, 305000239476, 30500X240336, 30500X241357, 305000241518, 30500X242172, 305000242249, 305000243252, 305000244364, 30500X245304, 305000244935, 305000245409, 305000245838, 30500X246522, 305000246308, 30500X246873, 30500X247609, 30500X248281, 305000249073, 3050RX241518, 3050RX233246, 3050RX242249, 3050RX228973, 30500X251061, 305000251056, 30500X251563, 3050RY252137, 305000252059, 305000252648, 305000254591, 30500X254931, 30500X255143, 305000255039, 305000255548, 305000256193, 305000256737, 305000257244, 305000257246, 305000257921, 305000257920, 305000258303, 305000258290, 30500X259383, 305000258793, 305000259573, 30500X260163, 305000259958, 305000259959, 3050RX254591, 3050RX255039, 305000260513, 305000260512, 30500Y261771, 3050RX257244, 3050RX257920, 305000261159, 305000261160, 3050RY262444, 30500X262443, 305000261734, 305000261732, 305000262325, 305000262326, 3050RX258303, 305000262976, 305000262975, 3050RY263510, 30500X263560, 305000263507, 305000263506, 305000264075, 305000264076, 305000264627, 305000264628, 30500X265424, 305000265525, 305000265524, 30500X265978, 30500X266143, 305000266063, 305000266064, 30500X266787, 305000266638, 305000266637, 305000267191, 30500X267470, 305000267423, 305000267675, 3050RY269957, 30500X274206  Catalog Number 110-4H: 3050RX198281, 3050RY194144, 3050RY198281, 3050RY200861, 30500X223154, 305000220948, 305000223622, 30500X225385, 30500X233417, 305000231714, 305000241350, 30500X243874, 305000250959, 30500X254932, 305000263557  Catalog Number 110-4L: 305000221383, 30500X222566, 305000222762, 30500X223971,305000223969, 305000225078, 30500X226539, 305000226221, 30500X227058, 305000226848, 305000226749, 305000226847, 305000226871, 305000226,870, 30500X228783, 305000229450, 305000229909, 305000230871 30500X232775, 305000232199, 30500X232961, 305000233311, 305000234438, 30500X235731, 305000235181, 305000236201, 305000237368, 305000237369, 305000237799, 305000238539, 305000239102, 30500X240245, 30500X240246, 30500X240247, 305000239736, 305000239737, 30500X241365, 30500X241522, 305000241082, 30500X242170, 30500X245765, 30500X246521, 3050RX237799, 3050RX226749, 3050RX229450, 3050RX241082, 3050RX232199, 3050RY252775, 3050RX240446, 3050RY255148, 305000259553, 305000260626, 305000261835, 305000262436, 3050RX259553, 305000263146, 3050RX260626, 305000264077, 3050RX262436, 3050RX261835, 305000264175, 3050RY265351, 3050RY265766, 305000265531, 30500X266144, 3050RY266146, 30500X266522, 305000266062, 305000267297, 30500X267473, 30500X268133, 305000267784, 305000268412, 3050RX265531, 305000268916, 3050RY271046, 305000271872, 30500X272374, 305000272591, 30500X274210, 30500X274963, 305000281820   Catalog Number 110-4BC: 176044, 177018, 178013, 178898, 179757, 180139, 180955, 182279, 182908, 184079, 184687, 185284, 186277, 187293, 190452, 187780, 190451, 191891, 193414, 194074, 195161, 195608, 196987, 197492, 198189, 198512, 200069, 200490, 199609, 201039, 201595, 202423, 203565, 207077, 208532  Catalog Number 110-4HC: 179758, 180956, 183071, 184686, 186278, 187781, 190450, 192246, 194993, 195450, 198191, 199708, 201040, 201596, 202009   Catalog Number 110-4LC: 162523, 167450, 167786, 175720, 177188, 178547, 182130, 187495, 195245, 197493.

Neurological Devices

2

No

Nationwide Distribution

Brand Names: Integra¿ Camino 110-4 Intracranial Pressure (ICP) Monitoring || Catheters. || Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. || The fully packaged 110-4B, 110-4H, and 110-4L catheters are || also provided as a component in kits that contain other cranial || access devices. These kits are Catalogue No. 110-4BC, 110- || 4HC, and 110-4LC respectively. || Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits || Classification Name: Device, Monitoring, Intracranial Pressure || 510(k) Number: K102875 || The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature.
The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space.
The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring.
The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage.
The Camino 110-4L catheter is intended for use with the Licox¿ Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.
The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively.

Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.

Neurological Devices

2

No

Worldwide Distribution - USA including Puerto Rico and the states of AZ, CA, FL, GA, IL, IN, KY, MA, MI, MS, NE, NM, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV., and the countries of Spain, Singapore, South Africa, Canada, Libya,Pakistan and Cayman Islands.

Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. || The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.

The Lot No's for the affected Gel Pads are Lot 093984 of part number# 440C1011 for Right Gel Pads

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY and the countries of: Canada and Belgium.

The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. || The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. || Product Usage: || The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.

The Lot No's for the affected Gel Pads are Lot 093990 of part number #440C1012 for Left Gel Pads

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US Nationwide including the states of AZ, CA, CO, DC, GA, IA, IL, IN, NC, and NY and the countries of: Canada and Belgium.

The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. || The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. || Product Usage: || The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD¿ system. The Left and Right Pads are mirror images.

Model number 643350 -- batch numbers 1045878, 1045879, 1045881, 1045880, 1045872, 1045882, 1045876, 1045877, 1045873, 1045874, and 1045875. Model number 643425 -- batch numbers 1045890, 1045886, 1045884, 1045887, 1045888, 1045889, and 1045885. Model number 643650 -- batch numbers 1045891, 1045892, and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895.

Obstetrical and Gynecological Devices

2

No

USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.

Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. || Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.