FDA device listing
Speculum and Kits, Disposable
FDA device listing 1323662694 · PRIME PACIFIC HEALTH INNOVATIONS CORPORATION
Key facts
| Proprietary names | Speculum and Kits, Disposable |
|---|---|
| Owner/operator | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION |
| Owner/operator number | 9035957 |
| Product codes | FFQ |
| Device names | FFQ - Speculum, Rectal |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.4730 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION |
| Establishment registrations | 9615415 |
| FEI numbers | 3006329956 |
| Establishment operations | Manufacturer, 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