FDA device listing
2"x3" Primapad Non-Adherent Dressing,2"x3" Reliamed Non-Adherent Dressing,3"x4" Primapad Non-Adherent Dressing,3"x8"…
FDA device listing 1856511716 · Sotera Health LLC
Key facts
| Proprietary names | 2"x3" Primapad Non-Adherent Dressing,2"x3" Reliamed Non-Adherent Dressing,3"x4" Primapad Non-Adherent Dressing,3"x8" Primapad Non-Adherent Dressing,Adhesive Bandage Coverlet,ALLEVYN Complete Care,ALLEVYN Gentle,Allevyn Life,Band-Aid,Biatain,Biatain Adhesive,Biatain Non-Adhesive,Biatain Silicone,Biatain Silicone Fit,Biatain Silicone Lite,Biatain Silicone Non-border,Biatain Soft-Hold,Biatain Super… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | NAD |
| Device names | NAD - Dressing, Wound, Occlusive |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4020 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Sterigenics Belgium (Fleurus) SRL, Sterigenics Belgium (Petit Rechain) SRL, Sterigenics Denmark A/S, Sterigenics Germany GmbH, Sterigenics Radiation Technologies IN, Inc, Sterigenics Shanghai E Beam Ltd., Sterigenics Shanghai ETO Ltd., Sterigenics UK Limited, STERIGENICS UK LIMITED, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1018470, 1058584, 1061124, 1319639, 1423662, 1526534, 1649518, 3002807090, 3002907620, 3004681519, 3005941719, 3006405073, 3007007790, 3008132398, 3008132411, 3009504230, 3015219237 |
| FEI numbers | 1018470, 1526534, 1000138054, 1000219637, 1000512168, 3000215273, 3001236277, 3002807091, 3002807111, 3002907620, 3003870583, 3006003617, 3006405073, 3007007790, 3008132411, 3009504230, 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