FDA Registration
Active
🇫🇷 France
OURY-GUYE & FILS
Reg #: 3002976036
·
FEI: 3002976036
·
Expires 2026
Products
32
Proprietary Names
14
Establishment Types
2
Classifications
32
Registration Details
- Registration Name
- OURY-GUYE & FILS
- Registration Number
- 3002976036
- FEI Number
- 3002976036
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 31 Rue Malaingre
- City
- NOGENT Haute-Marne
- Country
- FR
Owner / Operator
- Firm Name
- OURY-GUYE & Fils
- Operator Number
- 10043580
- Address
- 31 Rue Malaingre
- City
- NOGENT
- State
- Haute-Marne
- Postal Code
- 52800
- Country
- FR
- Correspondent
- Hennequin Magalie
US Agent
- Business Name
- Emergo Global Representation LLC
- Contact Name
- Yong Sun
- Address
- 2500 Bee Cave Rd., Bldg. 1, Ste. 300
- City
- Austin
- State
- TX
- ZIP
- 78746
- Country
- US
- [email protected]
- Phone
- 512 3279997
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2013-11-04 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2013-02-28 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2014-04-02 |
| Curette, Adenoid | KBJ | Class 1 | Ear, Nose, Throat | No | 2015-09-16 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-02-28 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-02-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-02-28 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-02-28 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-02-28 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2015-09-16 |
| Template | HWT | Class 1 | Orthopedic | No | 2014-11-17 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2015-09-16 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2013-02-28 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-11-04 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-02-28 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-11-04 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2022-09-27 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2013-02-28 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2013-02-28 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2015-09-16 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2013-11-04 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2017-03-17 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2013-11-04 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2013-02-28 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-02-28 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-11-04 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2013-02-28 |
| Knife, Tonsil | KBQ | Class 1 | Ear, Nose, Throat | No | 2015-09-16 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2013-11-04 |
| Prosthesis, Finger, Semi-Constrained, Metal/Polymer | SFA | Class 3 | Unknown | No | 2025-07-21 |
| Bender | HXW | Class 1 | Orthopedic | No | 2013-11-04 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2015-01-28 |
Proprietary Names
Ancillary set
Set Akin (Easyclip 08-10-12)
QUANTUM Talar and Insert Implant Holder
DISTRACTOR
JUDET HAMMER
GENERHIP
COMPRESSOR
BECKMANN RETRACTOR
ROD BENDER
ROD GRIPPER
ESIC ® PRESS
Retractor
BONE AWL
TOUCH® CMC 1
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device