FDA device listing
Barraquer Iris Spatula,Corneal Epithelium Spatula,Corneal Epithelium Spatula, Round,Daya Descemets Scraper,Excimer…
FDA device listing 1233188931 · Beaver-Visitec International, Inc.
Key facts
| Proprietary names | Barraquer Iris Spatula,Corneal Epithelium Spatula,Corneal Epithelium Spatula, Round,Daya Descemets Scraper,Excimer Spatula, Lindstrom / Vorkas,PRK Spatula,Spatula,Spatula, [Pearce], .80mm (45 Degree) |
|---|---|
| Owner/operator | Beaver-Visitec International, Inc. |
| Owner/operator number | 10033379 |
| Product codes | HND |
| Device names | HND - Spatula, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | Beaver-Visitec International, Inc., Beaver-Visitec International, Ltd, Malosa Medical Instruments (Changshu) Limited |
| Establishment registrations | 9680620, 3012733432, 3013421458 |
| FEI numbers | 3002808441, 3012733432, 3013421458 |
| Establishment operations | Contract Manufacturer, 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