FDA Registration
Active
🇺🇸 United States
MAST BIOSURGERY USA INC.
Reg #: 3004661493
·
FEI: 3004661493
·
Expires 2026
Products
3
Proprietary Names
8
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- MAST BIOSURGERY USA INC.
- Registration Number
- 3004661493
- FEI Number
- 3004661493
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6749 Top Gun St Ste 108
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072190
Owner / Operator
- Firm Name
- Mast Biosurgery USA
- Operator Number
- 9064241
- Address
- 6749 Top Gun St., Suite 108
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2008-11-04 |
| Barrier, Absorbable, Adhesion | MCN | Class 3 | Unknown | No | 2023-05-08 |
| Pericardial Patch To Facilitate Revision Surgeries | OMH | Class 2 | Cardiovascular | No | 2006-07-25 |
Proprietary Names
OrthoWrap
SURGIWRAP
SurgiWrap FROST
SurgiWrap Adhesion Barrier Film
SurgiWrap FROST Adhesion Barrier Film
CardioWrap Adhesion Barrier Film
OrthoWrap Adhesion Barrier Film
CARDIOWRAP
Establishment Types
Manufacture Medical Device
Manufacture Device in the United States for Export Only