FDA device listing
StrykerPR3324 (GR) - 10 G Bone Biopsy kit,StrykerPR3324 (GR, LS, VG) - 10 G Bone Biopsy kit,StrykerPR3324 (GR, LS, VG)…
FDA device listing 1600025375 · STERIS Corporation
Key facts
| Proprietary names | StrykerPR3324 (GR) - 10 G Bone Biopsy kit,StrykerPR3324 (GR, LS, VG) - 10 G Bone Biopsy kit,StrykerPR3324 (GR, LS, VG) - 11G Bone Biopsy Kit,StrykerPR3324 (GR, LS, VG) - iVAS Bone Biopsy Kit 10G, 11G, 13G,StrykerPR3324 (GR,VG) - 10G Biopsy Kit,StrykerPR3324 (GR,VG) - 13G Bone Biopsy Kit,StrykerPR3324 (GR,VG) - 8 Gauge Biopsy,StrykerPR3324 (GR,VG) - 9 10G Bone Biopsy Kit |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 1527821 |
| Product codes | KNW |
| Device names | KNW - Instrument, Biopsy |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1075 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Isomedix Operations, Inc., ISOMEDIX OPERATIONS INC, STERIS ISOMEDIX PUERTO RICO, INC. |
| Establishment registrations | 1424263, 1526711, 2648623 |
| FEI numbers | 1526711, 2648623, 3003015552 |
| Establishment operations | Contract Sterilizer |
| 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