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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2009-11-20 |
| Pusher, Band, Orthodontic | ECS | Class 1 | Dental | No | 1981-04-24 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2001-08-06 |
| Punch, Tonsil | KBT | Class 1 | Ear, Nose, Throat | No | 2003-09-04 |
| Retractor, Vaginal | HDL | Class 1 | Obstetrics/Gynecology | No | 1981-04-24 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2004-11-09 |
| Device, Monitoring, Intracranial Pressure | GWM | Class 2 | Neurology | No | 2017-09-26 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2015-06-15 |
| Reamer, Pulp Canal, Endodontic | EKP | Class 1 | Dental | No | 1992-08-26 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 1981-04-24 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2007-01-18 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 1981-04-24 |
| Balloon, Epistaxis | EMX | Class 1 | Ear, Nose, Throat | No | 2004-04-12 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 1981-04-24 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 1981-04-24 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2007-05-29 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 2003-08-05 |
| File | HTP | Class 1 | Orthopedic | No | 2003-09-04 |
| Forceps, Tube Introduction | BWB | Class 1 | Anesthesiology | No | 2003-08-05 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2003-09-04 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-09-26 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2001-08-06 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2001-12-04 |
| Point, Silver, Endodontic | EKL | Class 1 | Dental | No | 2001-12-04 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2001-12-04 |
| Table, Operating-Room, Manual | FSE | Class 1 | General, Plastic Surgery | No | 2007-06-27 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2003-09-04 |
| Remover, Crown | EIS | Class 1 | Dental | No | 1981-04-24 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2008-02-25 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 1981-04-24 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2004-11-09 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2010-09-21 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2006-08-03 |
| Marker, Periodontic | EMP | Class 1 | Dental | No | 1981-04-24 |
| Rongeur, Manual | HAE | Class 2 | Neurology | No | 2010-03-09 |
| Drills, Burrs, Trephines & Accessories (Compound, Powered) | HBF | Class 2 | Neurology | No | 2017-09-26 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2000-10-24 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 1992-08-26 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2003-08-05 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Scissors, Surgical Tissue, Dental | EGN | Class 1 | Dental | No | 1981-04-24 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2008-02-28 |
| Unit, Syringe, Air And/Or Water | ECB | Class 1 | Dental | No | 1992-08-26 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2003-09-04 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2018-09-10 |
| Manipulator, Plunger-Like Joint | LXM | Class U | Unknown | No | 2008-02-28 |
| Frame, Rubber Dam | EJE | Class 1 | Dental | No | 2001-12-04 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2005-03-23 |
| Scissors, Episiotomy | HDK | Class 1 | Obstetrics/Gynecology | No | 1981-04-24 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2004-06-04 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2003-08-05 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2003-09-04 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2000-12-14 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2001-12-04 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 1992-08-26 |
| Cannula, Injection | FGY | Class 1 | General, Plastic Surgery | No | 2015-03-30 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Laparoscopic Accessories, Gynecologic | NWV | Class 1 | Obstetrics/Gynecology | No | 2014-01-13 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2003-08-05 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2003-09-09 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1981-04-24 |
| General Purpose Dental Tray | OFX | Class 1 | Dental | No | 2020-07-30 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 1981-04-24 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 1981-04-24 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Saw, Manual And Accessories | GDR | Class 1 | General, Plastic Surgery | No | 2000-12-14 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2008-03-26 |
| Gutta-Percha | EKM | Class 1 | Dental | No | 1994-02-17 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 1981-04-24 |
| Clamp, Ossicle Holding | JYF | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Graft, Vascular, Stainless Steel Tunneler | MZY | Class 2 | Cardiovascular | No | 2013-03-18 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2005-01-18 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2001-08-06 |
| Sound, Urethral, Metal Or Plastic | FBX | Class 1 | Gastroenterology, Urology | No | 1981-04-24 |
| Forceps, Surgical, Gynecological | HCZ | Class 2 | Obstetrics/Gynecology | No | 2014-04-15 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 1981-04-24 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2007-05-29 |
| Needle, Suturing, Reusable | GDL | Class 1 | General, Plastic Surgery | No | 2004-04-12 |
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2004-11-09 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2003-09-09 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2008-04-09 |
| Needle, Tonsil Suturing | KBR | Class 1 | Ear, Nose, Throat | No | 2000-10-17 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Handpiece (Brace), Drill | HBD | Class 1 | Neurology | No | 2001-05-31 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2003-09-04 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2001-08-09 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Instrument, Cast Application/Removal, Manual | LGG | Class 1 | Orthopedic | No | 2003-09-04 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2011-05-19 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2000-12-14 |
| Ring, Laparotomy | FHI | Class 1 | Gastroenterology, Urology | No | 2015-02-04 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2004-06-04 |
| Snare, Ear | JZD | Class 1 | Ear, Nose, Throat | No | 2008-03-26 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Applier, Surgical, Clip | GDO | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Rongeur, Lachrymal Sac | HNG | Class 1 | Ophthalmic | No | 2008-03-26 |
| Hoe, Periodontic | EMQ | Class 1 | Dental | No | 2006-08-03 |
| Pinwheel | GWY | Class 1 | Neurology | No | 1981-04-24 |
| Forceps, Articulation Paper | EFK | Class 1 | Dental | No | 1981-04-24 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Endoscope, Rigid | GCM | Class 2 | Gastroenterology, Urology | No | 2009-11-19 |
| Instrument, Shunt System Implantation | GYK | Class 1 | Neurology | No | 2017-09-26 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2003-09-09 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2008-03-26 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2009-05-27 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 1981-04-24 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 1981-04-24 |
| Probe, Rectal, Non-Powered | EXX | Class 1 | Gastroenterology, Urology | No | 1981-04-24 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2011-05-24 |
| Snare, Nasal | KBE | Class 1 | Ear, Nose, Throat | No | 2003-09-04 |
| Adenotome | KBH | Class 1 | Ear, Nose, Throat | No | 1981-02-24 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 1997-01-14 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2003-08-05 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2001-12-04 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2004-11-09 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2008-03-25 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 1981-04-24 |
| Stripper, Vein, Reusable | GAI | Class 1 | General, Plastic Surgery | No | 2009-11-19 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 1981-04-24 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 1981-04-24 |
| Rongeur, Mastoid | JZA | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Catheter, Ventricular | HCA | Class 2 | Neurology | No | 2017-09-26 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 1981-04-24 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2007-06-27 |
| Cannula, Catheter | DQR | Class 2 | Cardiovascular | No | 2014-02-06 |
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2005-03-02 |
| Cannula, Ear | JYC | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2000-12-14 |
| Punch, Adenoid | KBS | Class 1 | Ear, Nose, Throat | No | 1981-02-24 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 1981-04-24 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2008-08-29 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2001-04-26 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2000-12-14 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Punch, Antrum | KAW | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2003-08-05 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Tenaculum, Uterine | HDC | Class 2 | Obstetrics/Gynecology | No | 2009-01-20 |
| Curette, Endodontic | EKT | Class 1 | Dental | No | 2001-12-04 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2007-06-27 |
| Bistoury, Tracheal | KCC | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 1981-04-24 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 1981-04-24 |
| Applier, Hemostatic Clip | HBT | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2000-10-24 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2017-09-27 |
| Strip, Polishing Agent | EHM | Class 1 | Dental | No | 2001-12-04 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2006-10-05 |
| Template | HWT | Class 1 | Orthopedic | No | 2001-04-26 |
| Forceps, Rubber Dam Clamp | EJG | Class 1 | Dental | No | 2003-09-04 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2004-06-04 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2000-12-14 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 1981-04-24 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2000-10-24 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2003-08-05 |
| Screw, Tonsil | KBX | Class 1 | Ear, Nose, Throat | No | 2003-09-04 |
| Clamp, Penile | FHA | Class 1 | Gastroenterology, Urology | No | 2009-11-13 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2003-08-05 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2021-01-19 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 2008-03-26 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2013-02-26 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 1992-08-26 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2001-04-26 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 1981-04-24 |
| Stainless Steel Instrument, Shunt System Implantation | PIY | Class 1 | Neurology | No | 2014-12-02 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2007-12-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2005-03-24 |
| Probe | HXB | Class 1 | Orthopedic | No | 2003-09-04 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2003-09-04 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 2003-09-04 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 1981-04-24 |
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Paper, Articulation | EFH | Class 1 | Dental | No | 1996-04-02 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Contractor, Surgical | FZR | Class 1 | General, Plastic Surgery | No | 2000-12-14 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2003-09-09 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Skid, Bone | HWO | Class 1 | Orthopedic | No | 1981-04-24 |
| Depressor, Tongue, Non-Surgical | FMA | Class 1 | General Hospital | No | 1981-04-24 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 1992-08-26 |
| Press, Vein | JYW | Class 1 | Ear, Nose, Throat | No | 2004-06-07 |
| Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material) | KHJ | Class 2 | Ear, Nose, Throat | No | 2015-01-19 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 1998-08-24 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1999-05-05 |
| Specula Accessories | FXG | Class 1 | General, Plastic Surgery | No | 2014-11-04 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2003-07-24 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2003-09-09 |
| Discriminator, Two-Point | GWI | Class 1 | Neurology | No | 2009-11-19 |
| Knife, Margin Finishing, Operative | EJZ | Class 1 | Dental | No | 2006-08-03 |
| Chisel, Mastoid | JYD | Class 1 | General, Plastic Surgery | No | 2003-08-04 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 1999-05-19 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2000-10-17 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2000-12-14 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 1981-04-24 |
| Tourniquet, Gastro-Urology | EYR | Class 1 | General, Plastic Surgery | No | 2004-06-04 |
| Rasp, Frontal-Sinus | KAZ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 1999-04-27 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2015-03-28 |
| Instrument, Contouring, Matrix, Operative | EKF | Class 1 | Dental | No | 2006-08-03 |
| Stylet For Catheter, Gastro-Urology | EZB | Class 1 | Gastroenterology, Urology | No | 2015-02-06 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Rongeur, Nasal | KBB | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 1981-04-24 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1981-04-24 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Cannula, Ventricular | HCD | Class 1 | Neurology | No | 2007-12-12 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2003-09-04 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2009-11-19 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 1999-05-10 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Speculum, Rectal | FFQ | Class 1 | Gastroenterology, Urology | No | 1981-04-24 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 2007-06-27 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 1992-08-26 |
| Percussor | GWZ | Class 1 | Neurology | No | 2013-04-22 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2003-08-05 |
| Clip, Scalp | HBO | Class 2 | Neurology | No | 2017-09-26 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2007-01-18 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2003-09-04 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2001-04-26 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2000-12-14 |
| Plate, Base, Shellac | EEA | Class 1 | Dental | No | 2001-12-04 |
| Magnet, Permanent | HPN | Class 1 | Ophthalmic | No | 1981-04-24 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2000-10-24 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2008-02-25 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2015-03-28 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2015-03-30 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 1981-04-24 |
| Packer, Uterine | HDM | Class 1 | Obstetrics/Gynecology | No | 1981-04-24 |
| Dynamometer, Nonpowered | HRW | Class 1 | Orthopedic | No | 1981-04-24 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1981-04-24 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2003-07-07 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2015-02-25 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2003-08-05 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2000-12-14 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2008-01-04 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2003-09-09 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1999-06-09 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2013-02-05 |
| Device, Locking, For Intestinal Clamp | FFR | Class 1 | Gastroenterology, Urology | No | 2009-11-13 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2006-11-27 |
| Inserter, Myringotomy Tube | JYM | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
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)