FDA device listing
Condom Catheter, External Catheter, Rusch Male Exeternal, Catheter
FDA device listing 1149721660 · Wuhan Sitaili Medical Apparatus Development Co.,Ltd
Key facts
| Proprietary names | Condom Catheter, External Catheter, Rusch Male Exeternal, Catheter |
|---|---|
| Owner/operator | Wuhan Sitaili Medical Apparatus Development Co.,Ltd |
| Owner/operator number | 10057778 |
| Product codes | NNY |
| Device names | NNY - Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | WUHAN SITAILI MEDICAL APPARATUS DEVELOPMENT CO.,LTD |
| Establishment registrations | 3011814545 |
| FEI numbers | 3011814545 |
| Establishment operations | 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