FDA device listing
Reprocessed Inflation Syringe,Reprocessed Manual ENT Instrument,Reprocessed Sinuplasty Balloon Catheter,Reprocessed…
FDA device listing 2046972356 · SURETEK MEDICAL
Key facts
| Proprietary names | Reprocessed Inflation Syringe,Reprocessed Manual ENT Instrument,Reprocessed Sinuplasty Balloon Catheter,Reprocessed Sinus Cannula |
|---|---|
| Owner/operator | SURETEK MEDICAL |
| Owner/operator number | 9082027 |
| Product codes | LRC |
| Device names | LRC - Instrument, Ent Manual Surgical |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4420 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | SURETEK MEDICAL |
| Establishment registrations | 3005575604 |
| FEI numbers | 3005575604 |
| Establishment operations | Reprocessor of Single Use Devices |
| 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