FDA device listing
2-CAN,Access Tool, Filler Placement Set,Access Tool, Filler Placement Stylet,ACL Disposable Kit,Ad-Tech…
FDA device listing 1178769473 · Sotera Health LLC
Key facts
| Proprietary names | 2-CAN,Access Tool, Filler Placement Set,Access Tool, Filler Placement Stylet,ACL Disposable Kit,Ad-Tech Cannulas,Autologous Platelet Concentrator Fluid Transfer Device (FTD),Bone Plug And Obturator,Cannula Surgical General and Plastic Surgery Cassi 2 Needle,Caps-Lock Ultra,Facet Screw Insruments,Integra; Jarit; MicroFrance; Miltex; Padgett; Xomed,MEDTRONIC Facet Screw Instruments,nContact… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | GEA |
| Device names | GEA - Cannula, Surgical, General & Plastic Surgery |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics UK Limited, Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1036836, 1054811, 1058584, 1319639, 1423662, 1526534, 1649518, 1721676, 2011171, 2029015, 2029275, 2953359, 3008132398 |
| FEI numbers | 1036836, 1526534, 1721676, 2011171, 1000114185, 1000138054, 1000160458, 1000219637, 1000306431, 3000215205, 3000215273, 3001236277, 3002807091 |
| 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