FDA device listing
General Procedure Tray
FDA device listing 2057421377 · UTAH MEDICAL PRODUCTS, INC.
Key facts
| Proprietary names | General Procedure Tray |
|---|---|
| Owner/operator | UTAH MEDICAL PRODUCTS, INC. |
| Owner/operator number | 1718873 |
| Premarket submissions | K882647 |
| Product codes | GBQ |
| Device names | GBQ - Catheter, Continuous Irrigation |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | UTAH MEDICAL PRODUCTS, INC. |
| Establishment registrations | 1718873 |
| FEI numbers | 1718873 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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