FDA device listing
DAN-33803NT Safersonic Single - No Tape,DAN-33803 Safersonic Single,DAN-33803U Safersonic Single Non Sterile,DAN-33805…
FDA device listing 1434635482 · PHARMASEPT LTD. MEDICAL PRODUCTS
Key facts
| Proprietary names | DAN-33803NT Safersonic Single - No Tape,DAN-33803 Safersonic Single,DAN-33803U Safersonic Single Non Sterile,DAN-33805 Safersonic Medium,DAN-33805U Safersonic Medium Non Sterile,DAN-33812 Safersonic Conti,DAN-33812U Safersonic Conti Non Sterile,DAN-33825 Safersonic Long,DAN-33825U Safersonic Long Non Sterile,S11103 Pajunk Labeled Safersonic Single,S11104 Pajunk Labeled Safersonic Conti |
|---|---|
| Owner/operator | PHARMASEPT LTD. MEDICAL PRODUCTS |
| Owner/operator number | 9045710 |
| Product codes | ITX |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic |
| 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