FDA device listing
BIKA,Bika for DCR,INFANT BIKA,Lacrimal Intubation Sets,MINI MONOKA,WIDE/MEDIUM COLLARETTE MONOKA, 3MM MEDIUM,WIDE/MEDIUM…
FDA device listing 1328294061 · Carl Zeiss Meditec AG (Jena)
Key facts
| Proprietary names | BIKA,Bika for DCR,INFANT BIKA,Lacrimal Intubation Sets,MINI MONOKA,WIDE/MEDIUM COLLARETTE MONOKA, 3MM MEDIUM,WIDE/MEDIUM COLLARETTE MONOKA, 4MM WIDE |
|---|---|
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Owner/operator number | 9053564 |
| Premarket submissions | K911109 |
| Product codes | OKS |
| Device names | OKS - Lacrimal Stents And Intubation Sets |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.OKS |
| 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 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