FDA device listing
BOWMAN PROBE, BOWMAN PROBE SIZE 00 & 0,BOWMAN PROBE, BOWMAN PROBE SIZE 1 & 2,BOWMAN PROBE, BOWMAN PROBE SIZE 3 & 4,Sizer…
FDA device listing 1579691765 · Carl Zeiss Meditec AG (Jena)
Key facts
| Proprietary names | BOWMAN PROBE, BOWMAN PROBE SIZE 00 & 0,BOWMAN PROBE, BOWMAN PROBE SIZE 1 & 2,BOWMAN PROBE, BOWMAN PROBE SIZE 3 & 4,Sizer for LacriJet,SIZER FOR SELF-RETAINING INTUBATION |
|---|---|
| Owner/operator | Carl Zeiss Meditec AG (Jena) |
| Owner/operator number | 9053564 |
| Product codes | HNL |
| Device names | HNL - Probe, Lachrymal |
| 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