FDA device listing
B-12 Prism Bar,B-16 Horizontal Prism Bar,Bishop Alignment Prism Set,BV-15 & B-16 Prism Bar Case Set,BV-15 & B-16 Prism…
FDA device listing 1484079674 · GULDEN OPHTHALMICS INC
Key facts
| Proprietary names | B-12 Prism Bar,B-16 Horizontal Prism Bar,Bishop Alignment Prism Set,BV-15 & B-16 Prism Bar Case Set,BV-15 & B-16 Prism Bar Set,BV-15 Vertical Prism Bar,Combination Horizontal / Vertical Prism Bar,LB-14 Large Vertical Prism Bar,LB-14 & LB-15 Large Prism Bar Set,LB-15 Large Horizontal Prism Bar,Magnetic Prism,Magnetic Stick,Magnetic Stick Prism,Magnetic Vergence Facility Prism,Magnetic Vergence… |
|---|---|
| Owner/operator | GULDEN OPHTHALMICS INC |
| Owner/operator number | 2518410 |
| Product codes | HKW |
| Device names | HKW - Prism, Bar, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 886.1650 |
| Review panels | Ophthalmic |
| Registered establishments | GULDEN OPHTHALMICS |
| Establishment registrations | 2518410 |
| FEI numbers | 2518410 |
| 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