FDA device listing
AdvMed8429 (BF) - McKesson Calcium Alginate Dressing,FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non…
FDA device listing 1493056726 · STERIS Corporation
Key facts
| Proprietary names | AdvMed8429 (BF) - McKesson Calcium Alginate Dressing,FirstWater14138 (RG) - DUP86122-9 - Xtrasorb Foam Non- Adhesive,FirstWater14138 (RG) - DUP86144-9 - Xtrasorb Foam Non- Adhesive,FirstWater14138 (RG) - DUP86188-9 - Xtrasorb Foam Non- Adhesive,FirstWater14138 (RG) - DUP86233-9 - Xtrasorb Foam Adhesive,FirstWater14138 (RG) - DUP86244-9 - Xtrasorb Foam Adhesive,FirstWater14138 (RG) - DUP86266-9… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10042227 |
| 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 | Synergy Health Ede BV, Synergy Health Ireland Ltd, Synergy Health Radeberg GMBH, Synergy Health Sterilisation UK Ltd, SYNERGY HEALTH STERILISATION UK LTD, Synergy Health (Thailand) Limited, Synergy Health Westport Ltd, Synergy Sterilisation (M) Sdn Bhd, Synergy Sterilisation South Africa Proprietary Ltd |
| Establishment registrations | 3002807310, 3002807314, 3002807315, 3008102042, 3009337401, 3010155648, 3010155661, 3010173425, 3010220595, 3010273867, 3010287685 |
| FEI numbers | 3002807036, 3002807310, 3002807314, 3002807315, 3002924544, 3009337401, 3010155648, 3010155661, 3010220595, 3010273867, 3010287685 |
| 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