FDA device listing
PuraStat-OM
FDA device listing 1574936859 · PHARMPUR GMBH
Key facts
| Proprietary names | PuraStat-OM |
|---|---|
| Owner/operator | PHARMPUR GMBH |
| Owner/operator number | 9058186 |
| Product codes | MGQ |
| Device names | MGQ - Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.MGQ |
| Review panels | General & Plastic Surgery |
| Registered establishments | PHARMPUR GMBH |
| Establishment registrations | 3005689226 |
| FEI numbers | 3005689226 |
| Establishment operations | Contract 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