FDA device listing
ActivHeal® Alginate,ActivHeal® AquaFiber™,ActivHeal® AquaFiber™ Extra,Biatain® Alginate,CalciCare™ Calcium Alginate…
FDA device listing 1046645235 · ADVANCED MEDICAL SOLUTIONS GROUP PLC
Key facts
| Proprietary names | ActivHeal® Alginate,ActivHeal® AquaFiber™,ActivHeal® AquaFiber™ Extra,Biatain® Alginate,CalciCare™ Calcium Alginate Dressing,CALCICARE™ REINFORCED Alginate,Cardinal Health™ Essential Reinforced Calcium Alginate Dressing,Cardinal Health Reinforced Gelling Fiber,Maxorb® Extra,Maxorb® Extra ES,McKesson Calcium Alginate Dressing,McKesson Gelling Fiber Dressings,Restore™ Calcium Alginate… |
|---|---|
| Owner/operator | ADVANCED MEDICAL SOLUTIONS GROUP PLC |
| Owner/operator number | 9031453 |
| 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 | Advanced Medical Solutions Ltd |
| Establishment registrations | 8044178 |
| FEI numbers | 3003080333 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 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