FDA device listing
BARDIC CYSTOSCOPIC IRRIGATION UNIT
FDA device listing 1214617098 · C. R. Bard, Inc.
Key facts
| Proprietary names | BARDIC CYSTOSCOPIC IRRIGATION UNIT |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Product codes | KOA |
| Device names | KOA - Surgical Instruments, G-U, Manual (And Accessories) |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.4730 |
| 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, Specification Developer |
| 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