Integra LifeSciences Corporation

Integra Integra Jarit Integra Miltex Jarit Miltex MicroFrance Ruggles-Redmond Fischer Fischer Cannula CODMAN Elsberg Ventricular Cannula Right Angle Guide CODMAN Mirror Finish Bipolar Forceps CODMAN Spetzler Mirror Finish Bipolar Forceps CODMAN MALIS Mirror Finish Bipolar Forceps CODMAN RHOTON Mirror Finish Bipolar Forceps CODMAN® YASARGIL Mirror Finish Bipolar Forceps Codman Surgical Pattie and Strip DuraSeal Exact Dural Sealant Tri-R Post Padgett Integra Padgett OraMem Absorbable Collagen Membrane BioMend Absorbable Collagen Membrane HeliMend Absorbable Collagen Membrane Padgett by Miltex Integra LICOX PT02 Monitor Acclarent AERA Eustachian Tube Balloon Dilation System DirectLink ICP Extension Cable Patient Monitor Interface Cables DirectLink ICP Module Hermetic TRAUMA CATHETER, VENTRICULAR CATHETER SET Codman Certas Toll Kit CODMAN CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM DuraGen Dural Graft Matrix CereLink ICP Sensor CODMAN EDS 3 - CSF External Drainage System CODMAN EDS 3 - CSF External Drainage System no Catheter Integra MicroFrance CODMAN® HAKIM® Valve Programmer CARB-BITE CODMAN Peel-Away Catheter Introducer Integral Drainage Set Integral Ventricular Drainge Set Integral Lumbar Drainge Set TruDi NAVWIRE TenoGlide Tendon Protector Medihoney Jarit Supercut 5-800 VENTRICULAR DRAINAGE SYSTEM Novus Valve System Codman Leroy Scalp Clip Adult Codman Leroy Scalp Clips Pediatric Codman Raney Scalp Clips Codman Leroy Raney Scalp Clips Codman Raney Scalp Clips Bulk Codman Leroy Raney Scalp Bulk DuraGen Plus Dural Regeneration Matrix CUSA Clarity Custom Cart Certas Plus Programmable Valve Integra Horizontal-Vertical Lumbar Valve System DuraSeal Dural Sealant SurgiMend PRS Meshed Collagen Matrix Revize-X Collagen Matrix Cytal Wound Matrix 2-Layer Cytal Burn Matrix Cytal Wound Matrix 3-Layer Cytal Wound Matrix 1-Layer Cytal Wound Matrix 6-Layer Relieva Spin Balloon Sinuplasty System Straight Ventricular Catheter Ventricular Catheter Accessory Kits CereLink ICP Monitor. CereLink ICP Extension Cable Extended Tip Applicator Cranial Access Kit Hand Drill CODMAN Bipolar Cords Relieva Tract Balloon Dilation System NeuraWrap Nerve Protector Acclarent Relieva Circa Ethmoid Punch Tactile Tone External CSF Drainage Systems Single Parameter Monitor SPM-1 Codman Microsensor Metal Skull Bolt Kit Codman Microsensor Ventricular Catheter Kit Codman Microsensor Plastic Skull Bolt Kit Codman Microsensor Ventricular Catheter Kit With Tuohyborst Adapter Codman Microsensor Basic Kit OSVII Integra Flow Regulating Valve Low Flow Integra Flow Regulator PriMatrix AG Equi-Flow Valve and Shunt Systems Inject-R-Fill Precise Precision MISHLER 2 CHAMB FLUSHING VALVE,ANTI-SYP DuraGen XS Dural Regeneration Matrix Relieva Sidekick LP Relieva Flex Guide Catheter 225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710 CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN® HAKIM® Programmable Valve; CODMAN® MEDOS® Ventricular Catheter Acclarent ENT Navigation System TEW Cranial /Spinal Retractor Syste PriMatrix ASX9/100 ASX9/130 Aurora Surgiscope System ASX9/70 ICB/ASX15 Padgett Sheen Grid Relieva Ultirra Sinus Balloon Catheter NeuraGen Nerve Guide 33-34-SH;33-35;33-35-SH;33-36;33-36-SH;33-37;33-38 33-31;33-31A;33-31AA;33-31AA-P/25;33-31A-P/25;33-31B;33-31-P/25;33-32;33-32-P/25;33-33;33-33-SH;33-34;33-34-P/25 Codman CRAK Kit Subdural Drainage Catheter Kits Polypropylene Connectors Codman® Electrosurgical lrrigator Codman® Electrosurgical Interconnecting Cable Hermetic Plus External CSF Drainage INTEGRA Dermal Regeneration Template INTEGRA Meshed Dermal Regeneration Template Integra Omnigraft Dermal Regeneration Matrix CUSA Clarity Ultrasonic Surgical Aspirator System; C7602; C7602EA CODMAN Integrated Bipolar Cord And Tubing Set CODMAN® HAKIM® Programmable Valve CUSA Clarity 23kHz CEM Nosecone Carb-N-Sert Diamond Peritoneal Introducer and Sheath Integra Gravity Compensating Accessory Integra DP Valve Systems Integra Licox Pt02 Monitor Accessories Malleable Tunneler Padgett Finger Splint Padgett Hand Splint OSVII and OSV Low Pro Valve Systems CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps Relieva Vortex 2 Cardion" for Pericardial Repair Covidien Air Assisted Sprayer Endoscopic Ventricular Catheter Mayfield Base Unit Wing-Grip CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters Arkis Subcutaneous Guidewire Loop Canulator / Canulator Gentrix Surgical Matrix Plus Gentrix Surgical Matrix Hiatal Gentrix Surgical Matrix Thin Gentrix Surgical Matrix NPH Low Flow Valve Integra Luxtec MLX 300 Watt Xenon Light Redmond Ruggles Mayfield MR/CT Skull Clamp Miltex Apex Root Locator MicroMatrix® UBM Particulate NeuroSight Arc Software Codman Disposable Perforators Integra Flexible EEG Cable Flexible EEG Cables Integra® Duo LED Surgical Headlight System CSF Reservoirs Integra Flow Regulating Valve Mayfield 2000 Radiolucent Skull Cla INTEGRA Wound Matrix INTEGRA Matrix Wound Dressing Biopatch CODMAN LEROY Scalp Clip Applier Forceps CODMAN RANEY Scalp Clip Forceps Codman Bactiseal Endoscopic Ventricular Catheter Mayfield Infinity XR2 Skull Clamp Licox IMC Complete Neuromonitoring Licox IT2 Complete Brain Tunneling Luxtec Light Sources Ultralite TruDi Navigation System Integra Meshed Bilayer Wound Matrix Luxtec MLX Light Source Disposable Shunt Passer Accudrain External CSF Drainage Sys CODMAN VPV SYSTEM, MODEL 82-3192 Roto-Lok Roto-Cam MicroMatrix Flex CODMAN Cranio-blade CODMAN Wire Pass Drill Wound Measuring Kit Hakim Percision Valve System Contour-Flex Valve and Shunt System Relieva SpinPlus Balloon Sinuplasty System CUSA EXCEL Ultrasonic Surgical Aspirator System Polypropylene Burr Hole Reservoir Mayfield Titanium Skull Pins Reusab Mayfield Titanium Skull Pins Dispos Spectra A EvenWet Lightning Spectra F CODMAN DISPOSABLE SCALP CLIP APPLIER CODMAN CERTAS Plus Electronic Tool Kit TruDi® Curette Mayfield Base Unit Adaptors Integra Omni-Tract Surgical Retractor Systems Relieva Luma Sentry Sinus Illumination System Codman Accessories Ventricular Kit Codman Accessories Cables Codman Accessories Drill Kit Codman Accessories ICP Transducer Basic Kit Codman Microsensor Intracranial Pressure Transducer and Accessories Codman Microsensor Codman Accessories Interface Control Unit Kit Codman Accessories Cranial Access Kit Codman Accessories Bolt Kit Codman Accessories Neuro Monitor Maurice Worldwide Shunt System Essential Shunt Kits Medihoney Honeycolloid Dressing OraMem Sustained Absorbable Collagen Membrane Biomend Extend Absorbable Collagen Membrane HeliMend Advanced Absorbable Collagen Membrane Alleghany CSF External Drainage Sys Pudenz Catheters Integra Reservoirs Braden Reservoir Pudenz Peritoneal Catheter Mishler Valve Systems Hermetic External CSF Drainage Syst Pudenz Valves On-Off Flushing Valves Multi-Purpose Valves Pudenz Cardiac Catheters Codman External Drainage System II Codman HAKIM PROGRAMMABLE VALVE SYSTEM Thompson CODMAN Disposable Perforators CUSA® Clarity 23 kHz Standard Laparoscopic Tip CUSA® Clarity 23 kHz Extended Laparoscopic Tip Jarit Rigid Endoscopes Arkis Tunneling Guidewire Arkis Precision Tunneler CODMAN® Disposable Catheter Passer CereLink ICP Replacement Power Supply 826822 CereLink ICP Replacement Battery 826824 CereLink ICP Extension Cable 826845 CereLink ICP Monitor 826820 ACCLARENT SE Inflation Device Integra LED Surgical Headlight SurgiMend MP Integra Straight Ventricular Catheter HeliTape Absorbable Collagen Wound Dressing CollaPlug Absorbable Collagen Wound Dressing HeliCote Absorbable Collagen Wound Dressing HeliPlug Absorbable Collagen Wound Dressing OraTape Absorbable Collagen Wound Dressing OraPlug Absorbable Collagen Wound Dressing CollaCote Absorbable Collagen Wound Dressing CollaTape Absorbable Collagen Wound Dressing Edwards Barbaro Syringo Shunt Syste Suturable DuraGen Dural Regenration Matrix Miltex Loupes LED Light Unit CODMAN Disposable ICP Kits Auragen Cortical Electrodes Spetzler Lumbar-Peritoneal System Integra Dermal Regeneration Template Single Layer Integra Dermal Regeneration Template Single Layer Thin Integra Meshed Dermal Regeneration Template (OUS) CODMAN MICROSENSOR Skull Bolt Kits MoniTorr ICP External CSF Drainage MicroMatrix INTEGRA Wound Matrix (Thin) Cyclops Multi-Angle Endoscope Miltex Cryosolutions 730410 730413 730612 730412 730614 730611 730613 730610 730511 730512 730411 730414 730510 Pudenz In-line Valve Systems Tardie Codman Ventricular Needles Subcutaneous Guidewire Arkis Subcutaneous Guideware Codman Electrosurgical Generator Codman Electrosurgical Foot Pedal Mayfield Adult Disposable Skull Pin Integral Ventricular Reservoir Ventricular Antichamber Depth Electrodes Strip Electrodes Grid Electrodes CODMAN® GHAJAR GUIDE® Ventriculostomy Kit Inspira Air Balloon Dilation System Ceram-A-Grip Grip Deep Xcision CARB-EDGE CUSA® Clarity 23 kHz Expanded CEM Nosecone Hermetic Lumbar Catheters Shur Strip Suture Strip UltraLite Gentrix" Surgical Matrix Thick SCHWARTZ VESSEL CL CODMAN® SCHWARTZ Clamp Forceps Integra Cranial Access Kit Probe 8" TruDi NAV Cable TruDi NAV Suction LICOX BRAIN OXYGEN MONITORING SYSTEM CATHETER PROBES AND KIT Acclarent Navwire Sinus Navigation Guidewire TruDi Shaver Blade LPV II Standard and Mini Valves CRW CRW Precision Arc Sterotactic System CRW-1 System Medihoney Gel Dressings CODMAN® ACCU-FLO® Straight Connector CODMAN® HOLTER® DuraGen Secure Dural Regeneration Matrix STERILE STD LPV WITH RIGHT ANGLE Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter Mayfield Composite Series Skull Clamp 4-322;4-323;4-325;4610;4611;4615 4-110;4-111;4-112;4-112B;4-115;4-115C;4-120;4-121;4-122;4-123;4-125;4-310;4-311;4-312;4-312B;4-315;4-315C;4-320;4-321 Fixott-Everett Grid (for x-ray film) OSVII Lumbar Valve System OSVII Low Flow Lumbar Valve Integra Ruggles Redmond CODMAN BACTISEAL EVD CATHETER SET Integra Drainage Accessory Kit Mayfield Infinity XR2 MR Skull Clamp INTEGRA Flowable Wound Matrix INTEGRA Bilayer Matrix Wound Dressing INTEGRA Bilayer Wound Matrix Sundt Shunt External Corotid Shunts Helistat Absorbable Collagen Hemostatic Sponge Helitene Absorbable Collagen Hemostatic Agent OraFOAM Absorbable Collagen Hemostatic Sponge SurgiMend -e Collagen Matrix SurgiMend 3 Collagen Matrix SurgiMend 4 Collagen Matrix SurgiMend 2 Collagen Matrix CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT Mayfield A-2000 Skull Clamp CODMAN Craniotomy Kit (consisting of Disposable Perforator, Cranio-blade, & Wire Pass Drill) Beauty Pink Mayfield Radiolucent Disposable Skull Pins Cytal® Wound Matrix Cytal® Burn Matrix Codman Double Lumen Skull Bolt Codman Single Lumen Skull Bolt Petit-Point GENERAL INSTRUMENT CODMAN® SCOTT Ventricular Cannula (Disposable) CABLES; CODMAN® ICP EXPRESS® Mayfield Infinity Skull Clamp CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) MoniTorr CSF External Drainage Syst RMH Integrator Silitone GripLite CODMAN® HAKIM® Programmable Valve with SIPHONGUARD® Device CODMAN® HAKIM® Precision Fixed Pressure Valve with SIPHONGUARD® Device Gravity Compensating Accessory CARDIO-GRIP MediHoney Alginate MediHoney 100% MediHoney Honeycolloid External Drainage Set Ruggles-Red Jarit Star Petit-Pt Jarit Super Tarbell-Loeffler Cosman Pediatric F Bactiseal EVD Catheter Sets: Bactiseal Clear EVD Catheter Set DuraSorb Monofilament Mesh Cyst Puncture Catheter Kits Integra Allograft Wedge Impactor Instrument Blade P4596 Cardio-Grip XKnife 5 Horizontal-Vertical Lumbar Valve System Spetzler Lumbar Peritoneal Shunt Systems Integra Disposable Filters 775-200 Integra Retention Plate 775-212-INT Mayfield Child Disposable Skull Pin SUCTION RESERVOIR KIT Integra Anti-Rotation Peg Holder Integra Allograft Wedge Sizer Instrument Integra Allograft Wedge Instrument Set 33-52;33-53;33-54;33-55;33-57 33-100;4-410;4-411;4-412;4-415;4-420;4-421;4-422;4-423;4-510;4-511;4-512;4-515;4-515C;4-522 Onyx-Flex Onyx-H Onyx-R CUSA Excel+ Ultrasonic Surgical Aspirator System; C2623; C5623; CUSAEXCEL2; C2600; C5601; C5602 Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System 5-700;5-702;5801;5803;5804 Mayfield MR/X-Ray Skull Clamp Nashold Biopsy Needle - Single Use Nashold Biopsy Needle - Disposable RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE CRW Biopsy Plus ACCLARENT PIVOT Balloon Dilation Systems Acclarent Inflation Device Dusor Elastic Bandage Surgilast Pressure Bandage Primacare Compriband Stockingnette BulkNet Flexoplast Suritube Primer Unna Boot Codman Instrument Tray Integra Allograft Wedge Instrument Tray Assembly Pudenz Flushing Valve TISSUEMEND DURAGEN PLUS ADHESION BARRIER MATRIX SUTURABLE DURAGEN DURAL REGENERATION METRIX Aurora Evacuator Covidien Flow Regulator Integra Stainless Steel Peritoneal Introducer Tunneling Guidewire Curity NG Strip Cath Strip White Cross First Aid Adhesive Bandages UC Strip METIS CODMAN BICOL Collagen Sponge HAKIM PROGRAMMABLE VALVE SYSTEM HAKIM MICRO PROGRAMMABLE VALVE SYSTEM SiphonGuard TM CSF Control Device HAKIM PRECISION VALVE SYSTEM STDSTEAM CODMAN HAKIM SHUNT SYSTEMS Articodent CerebroFlo EVD Catheter Arkis CerebroFlo EVD Catheter CRW Precision Arc Steriotactic System LumbarTrak Codman Bactiseal Ventricular Catheter TruDi Probe Gill-Thomas Cosman GTC Dental Tray CODMAN® BACTISEAL® Ventricular Catheter and Distal Catheter Kit Scout® Multi-Sinus Dilation System HV Valve System LCM-2-Linac Couch-Mount System NeuraGen 3D Nasostat Galea Elevator Arkis Galea Elevator Codman Hakim Programmable Valves Codman Hakim Precision Fixed Pressure Valves Integra Luxtec DLX UltraLite Pro Camera System TCC-EZ® MAYFIELD Skull Clamp MAYFIELD 2 Skull Clamp MicroMyst Applicator CODMAN® BACTISEAL® Clear EVD Catheter Codman Subarachnoid Screw Medihoney Dressing with Active Hone BUDDE Halo Retractor System Cosgrove Depth Electrode Kit LimiTorr Volume Limiting Drainage Hi-5 Mor-Flex Liberator Moyco Flex-R CUSA Clarity Ultrasonic Surgical Aspirator System; C7023; C7123; C7623; C7601; C7601EA Integra Luxtec UltraLitePro UltraLite Plus Mayfield Radiolucent Skull Clamp Mayfield Bactiseal Catheters Bactiseal Barium Striped Catheters Bactiseal Endoscopic Ventricular Catheter Codman Surgical Patties Micro Ventricular Bolt Pressure/Temperature Monitoring Kit AURORA Surgiscope System T Electron ICP Catheter MAYFIELD AURORA Evacuator + Coag Integra Luxtec DLX UltraLite Pro Luxtec Fiber Optic Cables Light Guide Cable Adapters Relieva Luma Light Guide Cable 2 CODMAN® BACTISEAL® Clear with Barium Stripe Catheter Kit Codman IsoCool Bipolar Forceps MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System Durepair Dura Regeneration Matrix CODMAN® MICROSENSOR® Ventricular Catheter Kit With ICP Sensor Medihoney Wound and Burn Dressing Right Angle Catheters SurgiMend 1 Collagen Matrix Revize Collagen Matrix SurgiMend PRS Collagen Matrix CUSA Clarity 23 kHz Single-Sided Bone Tip Codman Certas Plus Programmable Valves

Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Device in the United States for Export Only