FDA device listing
Atomic Edge® Knife,BeaverGuard Guarded Blade,Beaver Micro Knife,Beaver Micro-Sharp® Blade,Beaver Micro-Unitome…
FDA device listing 1990924670 · Beaver-Visitec International, Inc.
Key facts
| Proprietary names | Atomic Edge® Knife,BeaverGuard Guarded Blade,Beaver Micro Knife,Beaver Micro-Sharp® Blade,Beaver Micro-Unitome Knife,Beaver Mini-Blade®,Beaver Needle Blade,Beaver Optimum Knife,Beaver Pocket Blade,Beaver Sclerotome Blade,Beaver Sideport MVR Knife,Beaver® Swivel Fixation Ring 13mm,Beaver Xstar® Knives,Beaver® Xstar® Safety Slit Knife,Beaver Xstar® Slit Knife,EdgeAhead® Sideport MVR Knife,Visitec®… |
|---|---|
| Owner/operator | Beaver-Visitec International, Inc. |
| Owner/operator number | 10033379 |
| Product codes | HNN |
| Device names | HNN - Knife, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | Beaver-Visitec International, Inc., Beaver-Visitec International, Ltd, Grupo American Industries, S.A. de C.V |
| Establishment registrations | 1211998, 9680620, 3013421458, 3013466775 |
| FEI numbers | 1211998, 3002808441, 3013421458, 3013466775 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Manufacturer, Specification Developer |
| 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