FDA device listing
CopiOs® Pericardium Membrane,Tutodent® membrane
FDA device listing 1178424037 · RTI Surgical, Inc. (dba RTI Biologics, Inc.)
Key facts
| Proprietary names | CopiOs® Pericardium Membrane,Tutodent® membrane |
|---|---|
| Owner/operator | RTI Surgical, Inc. (dba RTI Biologics, Inc.) |
| Owner/operator number | 1641375 |
| Premarket submissions | K073097 |
| Product codes | NPL |
| Device names | NPL - Barrier, Animal Source, Intraoral |
| Device class | Class II |
| Classification regulations (21 CFR) | 872.3930 |
| Review panels | Dental |
| Registered establishments | RTI Surgical, Inc. (dba RTI Biologics, Inc.), Tutogen Medical GmBH |
| Establishment registrations | 3002719998, 3002924436 |
| FEI numbers | 3002719998, 3002924436 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database