FDA Registration
Active
🇺🇸 United States
Tutomesh® Bovine Pericardium
Reg #: 3002719998
·
FEI: 3002719998
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- RTI Surgical, Inc. (dba RTI Biologics, Inc.)
- Registration Number
- 3002719998
- FEI Number
- 3002719998
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 11621 Research Circle
- City
- ALACHUA
- State
- FL
- ZIP
- 32615
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081538
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 | FTM | Class 2 | General, Plastic Surgery | No | 2009-08-04 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | Class 2 | Cardiovascular | No | 2009-08-04 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2009-08-04 |
| Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | PAJ | Class 2 | General, Plastic Surgery | No | 2009-08-04 |
Proprietary Names
Tutomesh® Bovine Pericardium
Tutopatch® Bovine Pericardium
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility