FDA device listing
DAN-33505NWG Safersonic Medium Narrow with Gel,DAN-33512NWG Safersonic Conti Narrow with Gel,DAN-33803WG Safersonic…
FDA device listing 1705299875 · PHARMASEPT LTD. MEDICAL PRODUCTS
Key facts
| Proprietary names | DAN-33505NWG Safersonic Medium Narrow with Gel,DAN-33512NWG Safersonic Conti Narrow with Gel,DAN-33803WG Safersonic Single with Gel,DAN-33805WG Safersonic Medium with Gel,DAN-33812WG to Safersonic Conti with Gel,DAN-33825WG to Safersonic Long with Gel,S11101 Pajunk Labeled Safersonic Single with Gel,S11103 Pajunk Labeled Safersonic Conti with Gel |
|---|---|
| Owner/operator | PHARMASEPT LTD. MEDICAL PRODUCTS |
| Owner/operator number | 9045710 |
| Product codes | MUI |
| Device names | MUI - Media, Coupling, Ultrasound |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1570 |
| Review panels | Radiology |
| Registered establishments | PHARMASEPT LTD. MEDICAL PRODUCTS |
| Establishment registrations | 3003623887 |
| FEI numbers | 3003623887 |
| 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