FDA Registration
Active
🇺🇸 United States
DuraGen Secure Dural Regeneration Matrix
Reg #: 1121308
·
FEI: 1121308
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTEGRA LIFESCIENCES CORPORATION
- Registration Number
- 1121308
- FEI Number
- 1121308
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 105 and 109 MORGAN LANE
- City
- PLAINSBORO
- State
- NJ
- ZIP
- 08536
- Country
- US
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 |
|---|---|---|---|---|---|
| Dura Substitute | GXQ | Class 2 | Neurology | No | 2017-05-08 |
Proprietary Names
DuraGen Secure Dural Regeneration Matrix
SUTURABLE DURAGEN DURAL REGENERATION METRIX
DURAGEN PLUS ADHESION BARRIER MATRIX
DuraGen Dural Graft Matrix
Establishment Types
Manufacture Device in the United States for Export Only