FDA Registration
Active
🇩🇪 Germany
Tutopatch® Bovine Pericardium
Reg #: 3002924436
·
FEI: 3002924436
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Tutogen Medical GmBH
- Registration Number
- 3002924436
- FEI Number
- 3002924436
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Industriestrasse 6
- City
- Neunkirchen am Brand Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K991296
Owner / Operator
- Firm Name
- RTI Surgical, Inc. (dba RTI Biologics, Inc.)
- Operator Number
- 1641375
- Address
- 11621 Research Circle
- City
- Alachua
- State
- FL
- Postal Code
- 32615
- Country
- US
- Correspondent
- Amanda LoGuidice
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2006-03-22 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2006-03-22 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2006-03-22 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2006-03-22 |
Proprietary Names
Tutopatch® Bovine Pericardium
Establishment Types
Manufacture Medical Device