FDA device listing
BEAVER CORNEAL TREPHINE BLADE 10.0MM,BEAVER CORNEAL TREPHINE BLADE 10.5MM,BEAVER CORNEAL TREPHINE BLADE 11.0MM,BEAVER…
FDA device listing 1880626025 · Sotera Health LLC
Key facts
| Proprietary names | BEAVER CORNEAL TREPHINE BLADE 10.0MM,BEAVER CORNEAL TREPHINE BLADE 10.5MM,BEAVER CORNEAL TREPHINE BLADE 11.0MM,BEAVER CORNEAL TREPHINE BLADE 11.5MM,BEAVER CORNEAL TREPHINE BLADE 12.0MM,BEAVER CORNEAL TREPHINE BLADE 13.0MM,BEAVER CORNEAL TREPHINE BLADE 14.0MM,BEAVER CORNEAL TREPHINE BLADE 4.0MM,BEAVER CORNEAL TREPHINE BLADE 5.0MM,BEAVER CORNEAL TREPHINE BLADE 5.5MM,BEAVER CORNEAL TREPHINE BLADE… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HRH |
| Device names | HRH - Trephine, Manual, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | Sterigenics U.S. LLC, Sterigenics U.S., LLC |
| Establishment registrations | 1054811, 1319639, 2029275 |
| FEI numbers | 1000114185, 1000138054, 1000306431 |
| Establishment operations | Contract Sterilizer |
| 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