FDA device listing
Goncalves Invitria,INVITRIA INTRAVITREAL INJECTION ASSISTANT,Precivia Version I,Precivia Version I Non-Sterile,Precivia…
FDA device listing 1071899000 · Carl Zeiss Meditec AG (Jena)
Key facts
| Proprietary names | Goncalves Invitria,INVITRIA INTRAVITREAL INJECTION ASSISTANT,Precivia Version I,Precivia Version I Non-Sterile,Precivia Version P,Precivia Version P Non-Sterile |
|---|---|
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Owner/operator number | 9053564 |
| Product codes | HNC |
| Device names | HNC - Specula, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | FCI FRANCE CHIRURGIE INSTRUMENTATION, FCI SAS, FCI SUD |
| Establishment registrations | 9615745, 3002991496, 3004467263 |
| FEI numbers | 3000314405, 3002991496, 3004467263 |
| Establishment operations | Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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