FDA device listing
Instrument, biopsy,Jamshidi Bone Marrow Biopsy and Aspiration Tray,Jamshidi Bone Marrow Biopsy/Aspiration…
FDA device listing 1395361296 · C. R. Bard, Inc.
Key facts
| Proprietary names | Instrument, biopsy,Jamshidi Bone Marrow Biopsy and Aspiration Tray,Jamshidi Bone Marrow Biopsy/Aspiration Needle,Jamshidi Evolve Bone Marrow Biopsy and Aspiration Trays,Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle,Safe-T PLUS Trays,T-Handle Jamshidi Bone Marrow Biopsy and Aspiration Trays,T-Handle Jamshidi Bone Marrow Biopsy/Aspiration Needle |
|---|---|
| Owner/operator | C. R. Bard, Inc. |
| Owner/operator number | 2212754 |
| Premarket submissions | K171531 |
| Product codes | KNW |
| Device names | KNW - Instrument, Biopsy |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1075 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | BARD PERIPHERAL VASCULAR, INC., BARD REYNOSA S.A. DE C.V., C.R. BARD, INC. |
| Establishment registrations | 1018233, 2020394, 9617592, 3006082230 |
| FEI numbers | 1018233, 2020394, 3002468371, 3006082230 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Specification Developer |
| 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