FDA Registration
Active
🇫🇷 France
INTEGRA MICROFRANCE SAS
Reg #: 9680837
·
FEI: 3003249645
·
Expires 2026
Products
87
Proprietary Names
36
Establishment Types
4
Classifications
87
Registration Details
- Registration Name
- INTEGRA MICROFRANCE SAS
- Registration Number
- 9680837
- FEI Number
- 3003249645
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- LE PAVILLON
- City
- SAINT AUBIN LE MONIAL Auvergne-Rhone-Alpes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K993655
Owner / Operator
- Firm Name
- Integra LifeSciences Corporation
- Operator Number
- 9004007
- Address
- 1100 Campus Rd
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
US Agent
- Business Name
- Integra LifeSciences Corporation
- Contact Name
- Kerri DiPietro
- Address
- 11 Cabot Blvd
- City
- Mansfield
- State
- MA
- ZIP
- 02048
- Country
- US
- [email protected]
- Phone
- 774 7196909
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Nasal | KAS | Class 1 | Ear, Nose, Throat | No | 2004-11-09 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2003-09-04 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2004-11-09 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2015-03-28 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 1981-04-24 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2014-09-03 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2004-06-04 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2004-11-09 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2014-11-05 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2003-08-05 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 1998-12-31 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Snare, Tonsil | KBZ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2006-11-27 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2003-09-09 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2000-12-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2014-11-04 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Nipper, Malleus | JYR | Class 1 | Ear, Nose, Throat | No | 2007-01-18 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2003-09-04 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 1999-02-12 |
| Hook, Microsurgical Ear | JYL | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2015-03-28 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2000-10-17 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2008-03-25 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2015-01-19 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2015-08-06 |
| Knife, Ent | KTG | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Holder, Ear Speculum | JYK | Class 1 | General, Plastic Surgery | No | 1999-06-01 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2003-09-09 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2000-12-14 |
| Chisel, Nasal | KAN | Class 1 | General, Plastic Surgery | No | 2004-11-09 |
| Bone Particle Collector | MXP | Class 1 | Ear, Nose, Throat | No | 2015-06-02 |
| Pick, Microsurgical Ear | JYT | Class 1 | Ear, Nose, Throat | No | 1999-05-19 |
| Rod, Measuring Ear | JYZ | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2003-08-05 |
| Chisel, Middle-Ear | JYE | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Scissors, Nasal | KBD | Class 1 | Ear, Nose, Throat | No | 1999-05-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2000-10-24 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2003-09-09 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2003-07-07 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| 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 | 2015-01-19 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2015-01-19 |
| Loop, Wire | JYQ | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Knife, Laryngeal | JZY | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Scissors, Ear | JZB | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Excavator, Ear | JYH | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Punch, Nasal | KAY | Class 1 | Ear, Nose, Throat | No | 2014-11-04 |
| Block, Cutting, Ent, Non-Sterile | NNR | Class 1 | Ear, Nose, Throat | No | 2004-10-05 |
| Gouge, Nasal, Ent | KAQ | Class 1 | Ear, Nose, Throat | No | 2007-06-27 |
| Gauge, Measuring | JYJ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Dilator, Esophageal, Ent | KCF | Class 1 | Ear, Nose, Throat | No | 2015-03-28 |
| Press, Vein | JYW | Class 1 | Ear, Nose, Throat | No | 2004-06-07 |
| Punch, Ent | KTF | Class 1 | Ear, Nose, Throat | No | 2003-08-05 |
| Rasp, Ear | JYY | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2015-03-30 |
| Template | HWT | Class 1 | Orthopedic | No | 2001-04-26 |
| Die, Wire Bending, Ent, Non-Sterile | NNP | Class 1 | Ear, Nose, Throat | No | 2015-03-28 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Knife, Ear | JYO | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Source, Carrier, Fiberoptic Light | EQH | Class 1 | Ear, Nose, Throat | No | 2003-07-25 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2003-09-04 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2007-05-29 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 1999-06-09 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Elevator, Ent | KAD | Class 1 | Ear, Nose, Throat | No | 1981-04-24 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 1981-04-24 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2009-11-19 |
| Tray, Surgical, Ent | MMO | Class 1 | Ear, Nose, Throat | No | 2015-03-28 |
Proprietary Names
Padgett
Integra
MicroFrance
Miltex
Jarit
Ruggles-Redmond
Acclarent
Relieva Vortex 2
33-52;33-53;33-54;33-55;33-57
METIS
Integra Miltex
Integra Jarit
Petit-Point
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
Medtronic
Jarit Supercut
Carb-N-Sert
CARB-EDGE
5-700;5-702;5801;5803;5804
Wing-Grip
CODMAN Disposable Tunneler for Subcutaneous Placement of Catheters
Arkis Subcutaneous Guidewire
Loop Canulator / Canulator
GENERAL INSTRUMENT
Wound Measuring Kit
Galea Elevator
Arkis Galea Elevator
225520; 225525; P4480; P4835; P710; PM-4480; PM-4835; PM-710
CARB-BITE
Integra Luxtec DLX UltraLite Pro
Luxtec Fiber Optic Cables
Light Guide Cable Adapters
Relieva Luma Light Guide Cable 2
Thompson
Diamond
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)