FDA device listing
Prontosan
FDA device listing 1292383046 · B. BRAUN MELSUNGEN AG
Key facts
| Proprietary names | Prontosan |
|---|---|
| Owner/operator | B. BRAUN MELSUNGEN AG |
| Owner/operator number | 8010484 |
| Premarket submissions | K161623 |
| Product codes | FRO |
| Device names | FRO - Dressing, Wound, Drug |
| Device class | Unclassified |
| Classification regulations (21 CFR) | ORCA1.FRO |
| Review panels | General & Plastic Surgery |
| Registered establishments | B. Braun Medical AG, B. BRAUN MELSUNGEN AG |
| Establishment registrations | 9610825, 3007120504 |
| FEI numbers | 3002806469, 3007120504 |
| Establishment operations | Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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