FDA device listing
Bandages,BAND-AID® Brand Flexible Fabric Bandages,BAND-AID® Brand TOUGH STRIPS® Bandages,Breg,CovRsite,COVRSITE…
FDA device listing 1724265374 · Sotera Health LLC
Key facts
| Proprietary names | Bandages,BAND-AID® Brand Flexible Fabric Bandages,BAND-AID® Brand TOUGH STRIPS® Bandages,Breg,CovRsite,COVRSITE Plus,Dressings (Breg),Incise Film,KA1118/50,KA1124/100,KA1124/25,KA1154/25,KA1224/50,KA1254/25,KA2110/50,KA2130/50,KA2154/50,KA2210/25,KA2210/50,KA2211/25,KA2254/25,KA2310W/25,MTS003/100,OPSITE Flexigrid, IV3000 Ported,OPSITE Flexigrid, IV3000 Standard,OPSITE, IV3000 1-Hand,OPSITE… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | KGX |
| Device names | KGX - Tape And Bandage, Adhesive |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.5240 |
| Review panels | General Hospital |
| Registered establishments | Sterigenics Belgium (Petit Rechain) SRL, Sterigenics EO Canada, Inc., Sterigenics Radiation Technologies, LLC, Sterigenics Shanghai E Beam Ltd., Sterigenics Shanghai ETO Ltd., Sterigenics UK Limited, Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1018470, 1054811, 1058584, 1061124, 1423662, 1526534, 1649518, 1721676, 1721686, 2024024, 2029275, 9611665, 3004111573, 3005941719, 3007007790, 3008132398, 3008132411 |
| FEI numbers | 1018470, 1526534, 1721676, 1721686, 2024024, 1000114185, 1000219637, 1000306431, 1000512168, 3000215273, 3001236277, 3002807091, 3002807095, 3002807111, 3004111573, 3007007790, 3008132411 |
| 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