FDA device listing
25 set of Barraquer Wire Speculum,Aspiration Speculum for lasik,Barraquer Eye Speculum Adult Size,Barraquer, Iris…
FDA device listing 1528198946 · B&H Surgical Instrument
Key facts
| Proprietary names | 25 set of Barraquer Wire Speculum,Aspiration Speculum for lasik,Barraquer Eye Speculum Adult Size,Barraquer, Iris Spatula, Flat, 0.50 mm, 12.5 cm,Barraquer, Iris Spatula, Round, 0.25 mm, 12.5 cm,Barraquer Speculum, 14 mm, angled, temporal Overall Length 4 cm,Barraquer Wire Speculum,Barraquer Wire Speculum, Adult Size,Barraquer Wire Speculum (Set of 4 pcs),Cook Eye Speculum,Cook Eye Speculum, With… |
|---|---|
| Owner/operator | B&H Surgical Instrument |
| Owner/operator number | 10056927 |
| Product codes | HNC |
| Device names | HNC - Specula, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | B&H SURGICAL INSTRUMENT |
| Establishment registrations | 3013503739 |
| FEI numbers | 3013503739 |
| Establishment operations | 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