FDA device listing
11 guage Bone Access Needles,Anesthesia Peribulbar; Retrobulbar Needles,BackStop Plus,BONE BIOPSY NEEDLE,Cardinal blunt…
FDA device listing 1713746625 · Sotera Health LLC
Key facts
| Proprietary names | 11 guage Bone Access Needles,Anesthesia Peribulbar; Retrobulbar Needles,BackStop Plus,BONE BIOPSY NEEDLE,Cardinal blunt fill needle with filter,Cardinal blunt fill needle wwithout filter,CHIBA NEEDLE,Curity Amniocentesis Tray,Curity Thoracentesis Trays with Safety Components,Disposable Needles,Facet Screw Instruments,FNA - Fine Needle Aspiration,Homer Breast Localization Needles,Integra; Jarit… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GAA |
| Device names | GAA - Needle, Aspiration And Injection, Disposable |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics Shanghai ETO Ltd., Sterigenics UK Limited, STERIGENICS UK LIMITED, Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1018470, 1054811, 1061124, 1319639, 1423662, 1526534, 1649518, 1721676, 2011171, 2022435, 2029015, 2029275, 2953359, 3004111573, 3007007790, 3008132398, 3015219237 |
| FEI numbers | 1018470, 1526534, 1721676, 2011171, 2022435, 1000114185, 1000138054, 1000160458, 1000306431, 1000512168, 3000215205, 3000215273, 3001236277, 3002807091, 3004111573, 3007007790, 3015219237 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 10–99 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