FDA Registration Active 🇺🇸 United States

Integra LifeSciences Production Corporation

Reg #: 3014334038 · FEI: 3014334038 · Expires 2026
Products
277
Proprietary Names
228
Establishment Types
3
Classifications
277

Registration Details

Registration Name
Integra LifeSciences Production Corporation
Registration Number
3014334038
FEI Number
3014334038
Status
Active
Expiry Year
2026
Initial Importer
No
Address
11 Cabot Blvd.
City
Mansfield
State
MA
ZIP
02048
Country
US

Regulatory Submissions

510(k) Number
K932456

Owner / Operator

Firm Name
Integra LifeSciences Corporation
Operator Number
9004007
Address
1100 Campus Rd
City
Princeton
State
NJ
Postal Code
08540
Country
US

Products

Device Name Product Code
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) KNF
Pusher, Band, Orthodontic ECS
Chisel, Surgical, Manual FZO
Probe, Lachrymal HNL
Punch, Tonsil KBT
Retractor, Vaginal HDL
Rasp HTR
Device, Monitoring, Intracranial Pressure GWM
Scissors, Ear JZB
Elevator, Surgical, General & Plastic Surgery GEG
Shunt, Central Nervous System And Components JXG
Reamer, Pulp Canal, Endodontic EKP
Speculum, Vaginal, Metal HDF
Hook, Tracheal KCH
Nipper, Malleus JYR
Burr, Orthopedic HTT
Balloon, Epistaxis EMX
Burnisher, Operative EKJ
Excavator, Ear JYH
Forceps, Rongeur, Surgical EMH
Passer, Wire, Orthopedic HXI
Curette, Uterine HCY
File HTP
Forceps, Tube Introduction BWB
Fork, Tuning GWX
Elevator, Ent KAD
Electrosurgical, Cutting & Coagulation & Accessories GEI
Dilator, Lachrymal HNW
Wax, Dental, Intraoral EGD
Point, Silver, Endodontic EKL
Forceps, Dressing, Dental EFL
Table, Operating-Room, Manual FSE
Cystotome HNY
Remover, Crown EIS
Drills, Burrs, Trephines & Accessories (Manual) HBG
Forceps, Biopsy, Non-Electric FCL
Chisel, Nasal KAN
Evacuator, Oral Cavity EHZ
Instrument, Hand, Calculus Removal ELA
Marker, Periodontic EMP
Rongeur, Manual HAE
Drills, Burrs, Trephines & Accessories (Compound, Powered) HBF
Guide, Needle, Surgical GDF
File, Pulp Canal, Endodontic EKS
Mallet HXL
Hammer, Surgical FZY
Scissors, Surgical Tissue, Dental EGN
Source, Carrier, Fiberoptic Light EQH
Unit, Syringe, Air And/Or Water ECB
Probe And Director, Gastro-Urology FGM
Neurological Tray OJG
Manipulator, Plunger-Like Joint LXM
Frame, Rubber Dam EJE
Depressor, Metal Tongue, Surgical KBL
Trephine HWK
Scissors, Episiotomy HDK
Tamp HXG
Saw, Nasal KBC
Elevator HTE
Tube, Laryngectomy KAC
Spoon, Ophthalmic HNB
Disk, Abrasive EHJ
Retractor, Ent KAL
Mirror, Mouth EAX
Cannula, Injection FGY
Knife, Ent KTG
Laparoscopic Accessories, Gynecologic NWV
Spatula, Ophthalmic HND
Scissors, General, Surgical LRW
Forceps, Ophthalmic HNR
General Purpose Dental Tray OFX
File, Surgical, General & Plastic Surgery GEO
Retractor GAD
Elevator, Surgical, Dental EMJ
Carver, Dental Amalgam, Operative EKH
Rasp, Surgical, General & Plastic Surgery GAC
Saw, Manual And Accessories GDR
Handle, Instrument, Dental EJB
Gutta-Percha EKM
Retractor, All Types EIG
Clamp, Ossicle Holding JYF
Graft, Vascular, Stainless Steel Tunneler MZY
Stylet, Surgical, General & Plastic Surgery GAH
Bit, Drill HTW
Stripper, Surgical HRT
Sound, Urethral, Metal Or Plastic FBX
Forceps, Surgical, Gynecological HCZ
Pliers, Operative EJY
Marker, Skin FZZ
Needle, Suturing, Reusable GDL
Knife, Nasal KAS
Hemostat HRQ
Scalpel, One-Piece GDX
Syringe, Restorative And Impression Material EID
Needle, Tonsil Suturing KBR
Knife, Surgical EMF
Handpiece (Brace), Drill HBD
Curette, Ear JYG
Instrument, Cutting, Orthopedic HTZ
Knife, Laryngeal JZY
Instrument, Cast Application/Removal, Manual LGG
Tape, Measuring, Rulers And Calipers FTY
Laparoscope, General & Plastic Surgery GCJ
Awl HWJ
Ring, Laparotomy FHI
Pliers, Surgical HTC
Snare, Ear JZD
Hook, Microsurgical Ear JYL
Applier, Surgical, Clip GDO
Curette, Nasal KAP
Rongeur, Lachrymal Sac HNG
Hoe, Periodontic EMQ
Pinwheel GWY
Forceps, Articulation Paper EFK
Spatula, Surgical, General & Plastic Surgery GAF
Endoscope, Rigid GCM
Instrument, Shunt System Implantation GYK
Forceps HTD
Cannula, Ophthalmic HMX
Syringe, Cartridge EJI
Retractor, Self-Retaining FFO
Gag, Mouth KBN
Twister, Wire HXS
Probe, Rectal, Non-Powered EXX
Cannula, Sinus KAM
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
Snare, Nasal KBE
Adenotome KBH
Post, Root Canal ELR
Gouge, Surgical, General & Plastic Surgery GDH
Curette, Ophthalmic HNZ
Agent, Polishing, Abrasive, Oral Cavity EJR
Snare, Tonsil KBZ
Mirror, Ent KAI
Chisel, Middle-Ear JYE
Instrument, Ent Manual Surgical LRC
Dilator, Tracheal KCG
Ring Cutter FNS
Stripper, Vein, Reusable GAI
File, Bone, Surgical EMI
Knife, Periodontic EMO
Rongeur, Mastoid JZA
Catheter, Ventricular HCA
Rongeur HTX
Loop, Wire JYQ
Gouge, Nasal, Ent KAQ
Cannula, Catheter DQR
Container, Liquid Medication, Graduated KYW
Cannula, Ear JYC
Tray, Surgical, Instrument FSM
Punch, Adenoid KBS
Knife, Orthopedic HTS
Support, Patient Position CCX
Gauge, Depth HTJ
Trephine, Manual, Ophthalmic HRH
Rod, Measuring Ear JYZ
Punch, Antrum KAW
Knife, Myringotomy JYP
Osteotome, Manual GFI
Knife, Tonsil KBQ
Tenaculum, Uterine HDC
Curette, Endodontic EKT
Dissector, Tonsil KBM
Passer HWQ
Bistoury, Tracheal KCC
Carver, Wax, Dental EIK
Knife, Ear JYO
Forceps, Tooth Extractor, Surgical EMG
Applier, Hemostatic Clip HBT
Guide, Surgical, Instrument FZX
Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
Strip, Polishing Agent EHM
Goniometer, Nonpowered KQW
Template HWT
Forceps, Rubber Dam Clamp EJG
Syringe, Ent KCP
Knife, Ophthalmic HNN
Curette, Periodontic EMS
Hook, Ophthalmic HNQ
Retractor, Ophthalmic HNI
Screw, Tonsil KBX
Clamp, Penile FHA
Specula, Ophthalmic HNC
Clamp, Surgical, General & Plastic Surgery GDJ
Neurosurgical Paddie HBA
Carrier, Amalgam, Operative EKI
Clamp, Non-Electrical FFN
Tray, Impression, Preformed EHY
Impactor HWA
Scissors, Collar And Crown EIR
Stainless Steel Instrument, Shunt System Implantation PIY
Light Source, Fiberoptic, Routine FCW
Orthopedic Manual Surgical Instrument LXH
Probe HXB
Needle, Ophthalmic Suturing HNM
Cutter, Surgical FZT
Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
Instruments, Surgical, Cardiovascular DWS
Knife, Amputation GDN
Paper, Articulation EFH
Trocar, Ent KTE
Contractor, Surgical FZR
Holder, Needle, Gastroenterologic FHQ
Punch, Nasal KAY
Skid, Bone HWO
Depressor, Tongue, Non-Surgical FMA
Spreader, Pulp Canal Filling Material, Endodontic EKK
Press, Vein JYW
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) KHJ
Punch, Ent KTF
Mallet, Surgical, General & Plastic Surgery GFJ
Instrument, Microsurgical GZX
Scissors, Nasal KBD
Specula Accessories FXG
Syringe, Irrigating (Non Dental) KYZ
Scissors, Ophthalmic HNF
Discriminator, Two-Point GWI
Knife, Margin Finishing, Operative EJZ
Chisel, Mastoid JYD
Pick, Microsurgical Ear JYT
Probe, Ent KAK
Scoop FHL
Forceps, Biopsy, Gynecological HFB
Tourniquet, Gastro-Urology EYR
Rasp, Frontal-Sinus KAZ
Instrument, Surgical, Non-Powered HAO
Tray, Surgical, Ent MMO
Instrument, Contouring, Matrix, Operative EKF
Stylet For Catheter, Gastro-Urology EZB
Applicator, Ent KCJ
Rongeur, Nasal KBB
Plier, Orthodontic JEX
Catheter And Tip, Suction JOL
Rasp, Nasal KBA
Cannula, Ventricular HCD
Blade, Scalpel GES
Forceps, Wire Holding HYA
Caliper KTZ
Tube, Ear Suction JZF
Speculum, Rectal FFQ
Forceps, General & Plastic Surgery GEN
Expander, Surgical, Skin Graft FZW
Gauge, Depth, Instrument, Dental EIL
Percussor GWZ
Curette, Surgical, General Use FZS
Clip, Scalp HBO
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
Cotton, Roll EFN
Speculum, Ent EPY
Gauge, Measuring JYJ
Screwdriver HXX
Dissector, Surgical, General & Plastic Surgery GDI
Plate, Base, Shellac EEA
Magnet, Permanent HPN
Instrument, Manual, Surgical, General Use MDM
Laparoscope, Gynecologic (And Accessories) HET
Bur, Ear, Nose And Throat EQJ
Table And Attachments, Operating-Room BWN
Caliper, Ophthalmic HOE
Packer, Uterine HDM
Dynamometer, Nonpowered HRW
Cutter, Wire HXZ
Needle, Aspiration And Injection, Disposable GAA
Adaptor, Bulbs, Miscellaneous, For Endoscope FFY
Punch, Surgical LRY
Rasp, Ear JYY
Spud, Ophthalmic HNA
Holder, Film, X-Ray EGZ
Hook, Surgical, General & Plastic Surgery GDG
Clamp HXD
Curette, Adenoid KBJ
Forceps, Ent KAE
Nasopharyngoscope (Flexible Or Rigid) EOB
Device, Locking, For Intestinal Clamp FFR
Osteotome HWM
Inserter, Myringotomy Tube JYM
Handle, Scalpel GDZ

Proprietary Names

Jarit Supercut Roto-Lok Roto-Cam Jarit Miltex Integra Ruggles-Redmond Padgett MicroFrance 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 Miltex Integra Jarit CODMAN® BACTISEAL® Clear EVD Catheter Nasostat CerebroFlo EVD Catheter Arkis CerebroFlo EVD Catheter Integra Flow Regulating Valve CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps CABLES; CODMAN® ICP EXPRESS® Beauty Pink Carb-N-Sert CODMAN EDS 3 - CSF External Drainage System Codman Double Lumen Skull Bolt Codman Single Lumen Skull Bolt CODMAN Disposable ICP Kits Codman Subarachnoid Screw Tactile Tone CODMAN Disposable Perforators Codman Certas Plus Programmable Valves Hi-5 Mor-Flex Liberator Moyco Flex-R OSVII Lumbar Valve System OSVII Low Flow Lumbar Valve Codman Electrosurgical Generator Codman Electrosurgical Foot Pedal UltraLite Codman HAKIM PROGRAMMABLE VALVE SYSTEM Probe 8" Integra MicroFrance Codman CRAK Kit CARB-EDGE 5-700;5-702;5801;5803;5804 LICOX BRAIN OXYGEN MONITORING SYSTEM CATHETER PROBES AND KIT T Electron Galea Elevator Arkis Galea Elevator CARB-BITE RMH Integrator Silitone GripLite Inject-R-Fill Precise Precision 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® Electrosurgical lrrigator Codman® Electrosurgical Interconnecting Cable CODMAN CERTAS PLUS PROGRAMMAGLE VALVE SYSTEM Cardio-Grip Petit-Point 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 5-800 Wound Measuring Kit CODMAN Integrated Bipolar Cord And Tubing Set CODMAN LEROY Scalp Clip Applier Forceps CODMAN RANEY Scalp Clip Forceps CODMAN® ACCU-FLO® Straight Connector CODMAN® HOLTER® CODMAN® HAKIM® Programmable Valve CODMAN® HAKIM® Precision Fixed Pressure Valve CODMAN Peel-Away Catheter Introducer GENERAL INSTRUMENT Relieva Sidekick LP Acclarent Relieva Flex Guide Catheter Codman Disposable Perforators Tri-R Post CODMAN® MICROSENSOR® Ventricular Catheter Kit With ICP Sensor Hakim Percision Valve System CereLink ICP Replacement Power Supply 826822 CereLink ICP Replacement Battery 826824 CereLink ICP Extension Cable 826845 CereLink ICP Monitor 826820 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 CODMAN Bipolar Cords CODMAN® BACTISEAL® Clear with Barium Stripe Catheter Kit Jarit Rigid Endoscopes DirectLink ICP Extension Cable Patient Monitor Interface Cables DirectLink ICP Module Codman Instrument Tray Integra Allograft Wedge Instrument Tray Assembly CODMAN Craniotomy Kit (consisting of Disposable Perforator, Cranio-blade, & Wire Pass Drill) CODMAN® HAKIM® Programmable Valve with SIPHONGUARD® Device CODMAN® HAKIM® Precision Fixed Pressure Valve with SIPHONGUARD® Device Codman IsoCool Bipolar Forceps 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 External CSF Drainage Systems Pudenz Cardiac Catheters Codman External Drainage System II External Drainage Set Thompson CODMAN BACTISEAL EVD CATHETER SET CODMAN HAKIM SHUNT SYSTEMS Ceram-A-Grip Grip Deep Xcision CODMAN CERTAS Plus Electronic Tool Kit LumbarTrak SCHWARTZ VESSEL CL CODMAN® SCHWARTZ Clamp Forceps CODMAN Cranio-blade CODMAN Wire Pass Drill Spectra A EvenWet Lightning Spectra F 225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710 CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT CODMAN® SCOTT Ventricular Cannula (Disposable) Arkis Subcutaneous Guidewire Arkis Tunneling Guidewire Arkis Precision Tunneler CODMAN® Disposable Catheter Passer Bactiseal EVD Catheter Sets: Bactiseal Clear EVD Catheter Set Codman Surgical Pattie and Strip Integra Allograft Wedge Impactor Instrument Integra Stainless Steel Peritoneal Introducer Tunneling Guidewire Luxtec Light Sources Ultralite Integra Anti-Rotation Peg Holder Integra Allograft Wedge Sizer Instrument Integra Allograft Wedge Instrument Set Ruggles-Red Jarit Star Petit-Pt Jarit Super CARDIO-GRIP Articodent NPH Low Flow Valve Onyx-Flex Onyx-H Onyx-R Luxtec MLX Light Source CODMAN® BACTISEAL® Ventricular Catheter and Distal Catheter Kit Codman Codman Ventricular Needles Subcutaneous Guidewire Arkis Subcutaneous Guideware CODMAN MICROSENSOR Skull Bolt Kits HAKIM PROGRAMMABLE VALVE SYSTEM HAKIM MICRO PROGRAMMABLE VALVE SYSTEM SiphonGuard TM CSF Control Device HAKIM PRECISION VALVE SYSTEM Fischer Fischer Cannula CODMAN Elsberg Ventricular Cannula 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 Licox IMC Complete Neuromonitoring Licox IT2 Complete Brain Tunneling Diamond Blade P4596 33-52;33-53;33-54;33-55;33-57 CODMAN DISPOSABLE SCALP CLIP APPLIER Codman Hakim Programmable Valves Codman Hakim Precision Fixed Pressure Valves CODMAN® HAKIM® Programmable Valve; CODMAN® MEDOS® Ventricular Catheter CereLink ICP Monitor. CereLink ICP Extension Cable 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 OSVII and OSV Low Pro Valve Systems Wing-Grip CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters Loop Canulator / Canulator Bactiseal Catheters Bactiseal Barium Striped Catheters Bactiseal Endoscopic Ventricular Catheter Mayfield Base Unit Codman Certas Toll Kit Codman Bactiseal Ventricular Catheter CODMAN® GHAJAR GUIDE® Ventriculostomy Kit 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® HAKIM® Valve Programmer CereLink ICP Sensor CODMAN VPV SYSTEM, MODEL 82-3192 CODMAN BICOL Collagen Sponge METIS Codman Surgical Patties

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)