FDA device listing
17 ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point,17 ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba…
FDA device listing 2002398241 · Sotera Health LLC
Key facts
| Proprietary names | 17 ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point,17 ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point,17 ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba Point,17 ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point,17 ga, 45mm Always-On Tip Tracked Biopsy Needle, Chiba Point,17 ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point,17 ga LG, 123mm Always-On Tip… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | JAK |
| Device names | JAK - System, X-Ray, Tomography, Computed |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1750 |
| Review panels | Radiology |
| Registered establishments | Sterigenics US LLC |
| Establishment registrations | 3002907620 |
| FEI numbers | 3002907620 |
| 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