FDA device listing
Advadraw,Advadraw Spiral,Advazorb,Advazorb Areola,Advazorb Border,Advazorb Border Lite,Advazorb Fixation,Advazorb…
FDA device listing 1982221930 · Sotera Health LLC
Key facts
| Proprietary names | Advadraw,Advadraw Spiral,Advazorb,Advazorb Areola,Advazorb Border,Advazorb Border Lite,Advazorb Fixation,Advazorb Heel,Advazorb Sacral,Advazorb Silfix,Aquacel Extra,AQUACEL Foam,AQUACEL Foam Pro,Aquacel WSF,Carboflex,ConvaFoam Border,ConvaFoam Non-Adhesive,ConvaFoam Silicone,Dressing, Wound Hydrophilie,Eclypse,Eclypse Adherent,Eclypse Adherent Sacral,Eclypse Boot,Eclypse Border & Border… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | NAC |
| Device names | NAC - Dressing, Wound, Hydrophilic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4018 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics Belgium (Fleurus) SRL, Sterigenics Belgium (Petit Rechain) SRL, Sterigenics Germany GmbH, Sterigenics Radiation Technologies, LLC, Sterigenics Shanghai E Beam Ltd., Sterigenics UK Limited, STERIGENICS UK LIMITED, Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1018470, 1058584, 1061124, 1423662, 1649518, 1721686, 2024024, 2029275, 3002807090, 3002907620, 3004681519, 3005941719, 3008132398, 3008132411, 3015219237 |
| FEI numbers | 1018470, 1721686, 2024024, 1000219637, 1000306431, 1000512168, 3000215273, 3001236277, 3002807091, 3002807111, 3002907620, 3003870583, 3006003617, 3008132411, 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