FDA device listing
Bard Malleable Tip Catheter Stylet,Bard Nitinol Guidewires,Bard Van Buren Curve Catheter Style,Hyrdo-Glide Guidewire,J…
FDA device listing 1552653359 · C. R. Bard, Inc.
Key facts
| Proprietary names | Bard Malleable Tip Catheter Stylet,Bard Nitinol Guidewires,Bard Van Buren Curve Catheter Style,Hyrdo-Glide Guidewire,J Guidewires,NiCore Nitinol Guidewires |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Product codes | EZB |
| Device names | EZB - Stylet For Catheter, Gastro-Urology |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5130 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | C.R. BARD, INC., DAVOL SURGICAL INNOVATIONS, PRODUCTOS PARA EL CUIDADO DE LA SALUD |
| Establishment registrations | 1018233, 1313046, 9611590, 9616067, 3006082230 |
| FEI numbers | 1018233, 1313046, 1000237915, 3001436772, 3006082230 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Specification Developer, 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