FDA device listing
Bardex Silicone Foley Catheter,Bardex Silicone Foley Catheter (offered in strips and trays)
FDA device listing 1548604562 · C. R. Bard, Inc.
Key facts
| Proprietary names | Bardex Silicone Foley Catheter,Bardex Silicone Foley Catheter (offered in strips and trays) |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Premarket submissions | K760093 |
| Product codes | GBM |
| Device names | GBM - Catheter, Urethral |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5130 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | C.R. BARD, INC., PRODUCTOS PARA EL CUIDADO DE LA SALUD |
| Establishment registrations | 1018233, 9611590, 3006082230 |
| FEI numbers | 1018233, 1000237915, 3006082230 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, 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