FDA Registration
Active
🇫🇷 France
Bandloc Sterile Implant
Reg #: 9616062
·
FEI: 3003258310
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cousin Biotech
- Registration Number
- 9616062
- FEI Number
- 3003258310
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ALLEE DES ROSES
- City
- WERVICQ-SUD Nord
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K200097
Owner / Operator
- Firm Name
- Cousin Surgery
- Operator Number
- 9043669
- Address
- Allee des roses
- City
- Wervicq-Sud
- State
- Nord
- Postal Code
- 59117
- Country
- FR
- Correspondent
- FRANCK - PELLETIER
US Agent
- Business Name
- ProMedic, LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr NE
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2023-12-21 |
Proprietary Names
Bandloc Sterile Implant
Bandloc Duo Sterile Implant
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)