FDA device listing
Accessory - Foam Strips,AllPoints™ Dressing Change Kit,Sensor Holder,Sentrinex™ 3D Port Dressing,Statlock Stabilization…
FDA device listing 1855942538 · C. R. Bard, Inc.
Key facts
| Proprietary names | Accessory - Foam Strips,AllPoints™ Dressing Change Kit,Sensor Holder,Sentrinex™ 3D Port Dressing,Statlock Stabilization Device,Wound Closure Tape Strips |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Product codes | KGX |
| Device names | KGX - Tape And Bandage, Adhesive |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5240 |
| Review panels | General Hospital |
| Registered establishments | Bard Access Systems, Inc., BARD REYNOSA S.A. DE C.V., C.R. BARD, INC., DAVOL SURGICAL INNOVATIONS, PRODUCTOS PARA EL CUIDADO DE LA SALUD |
| Establishment registrations | 1018233, 9611590, 9616067, 9617592, 3006082230, 3006260740 |
| FEI numbers | 1018233, 1000237915, 3001436772, 3002468371, 3006082230, 3006260740 |
| Establishment operations | Contract Manufacturer, Repackager/Relabeler, 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