FDA Registration
Active
🇩🇪 Germany
CopiOs® Pericardium Membrane
Reg #: 3002924436
·
FEI: 3002924436
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
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
- K073097
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 |
|---|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | Class 2 | Dental | No | 2008-07-23 |
Proprietary Names
CopiOs® Pericardium Membrane
Tutodent® membrane
Establishment Types
Manufacture Medical Device