FDA device listing
Aspiration speculum for LASIK, with ports for removing fluid, blade 15 mm,Barraquer Speculum Solid blade, 14 mm, angled…
FDA device listing 1198604671 · Stellmacher Instruments Inc
Key facts
| Proprietary names | Aspiration speculum for LASIK, with ports for removing fluid, blade 15 mm,Barraquer Speculum Solid blade, 14 mm, angled, overall length 4 cm,Barraquer Wire Speculum Adult size heavy wire, blade 15 m,Barraquer Wire Speculum Adult size standard wire, blade 15 mm,Barraquer Wire Speculum Baby size, blade 8 mm,Barraquer Wire Speculum Child size, blade 13 mm,Barraquer Wire Speculum Neonatal, blade 5… |
|---|---|
| Owner/operator | Stellmacher Instruments Inc |
| Owner/operator number | 10088967 |
| Product codes | HNC |
| Device names | HNC - Specula, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.4350 |
| Review panels | Ophthalmic |
| Registered establishments | STELLMACHER INSTRUMENTS INC |
| Establishment registrations | 3029754081 |
| FEI numbers | 3029754081 |
| Establishment operations | Repackager/Relabeler |
| 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