FDA Registration
Active
🇺🇸 United States
Integra LifeSciences Braintree Inc.
Reg #: 3004170064
·
FEI: 3004170064
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Integra LifeSciences Braintree Inc.
- Registration Number
- 3004170064
- FEI Number
- 3004170064
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 400b Wood Rd
- City
- Braintree
- State
- MA
- ZIP
- 02184
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153690
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 |
|---|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | Class U | Unknown | No | 2023-03-06 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2017-04-21 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2015-08-03 |
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2024-03-11 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2017-08-03 |
Proprietary Names
PriMatrix
SurgiMend MP
SurgiMend 1 Collagen Matrix
Revize Collagen Matrix
SurgiMend PRS Collagen Matrix
PriMatrix AG
SurgiMend -e Collagen Matrix
SurgiMend 3 Collagen Matrix
SurgiMend 4 Collagen Matrix
SurgiMend 2 Collagen Matrix
Durepair Dura Regeneration Matrix
TISSUEMEND
SurgiMend PRS Meshed Collagen Matrix
Revize-X Collagen Matrix
Establishment Types
Manufacture Medical Device