FDA device listing
SUPER SETON
FDA device listing 1347839236 · F CARE SYSTEMS USA
Key facts
| Proprietary names | SUPER SETON |
|---|---|
| Owner/operator | F CARE SYSTEMS USA |
| Owner/operator number | 10035152 |
| Product codes | GBN |
| Device names | GBN - Catheter, Pediatric, General & Plastic Surgery |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4200 |
| Review panels | General & Plastic Surgery |
| Registered establishments | F CARE SYSTEMS USA |
| Establishment registrations | 3008816935 |
| FEI numbers | 3009438986 |
| Establishment operations | Repackager/Relabeler |
| 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