FDA device listing
BioGuard valves (3-pc) & air/water cleaning adapter kit (00711786) (EN-CFE),BioGuard valves (4-pc) & air/water cleaning…
FDA device listing 1964173070 · STERIS Corporation
Key facts
| Proprietary names | BioGuard valves (3-pc) & air/water cleaning adapter kit (00711786) (EN-CFE),BioGuard valves (4-pc) & air/water cleaning adapter kit (00711787) (EN-CFE),BioGuard valves & air/water cleaning adapter kit (00711785) (EN-CFE),DEFENDO Olympus EUS Air Water Suction Valve - Linear Biopsy Valve (0711901) (EN-MF),DEFENDO Olympus EUS Air Water Suction Valve - Radial Biopsy Valve (0711904) (EN-MF),Via… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Product codes | NWU |
| Device names | NWU - Endoscope Introducer Kit |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | UNITED STATES ENDOSCOPY GROUP, INC. |
| Establishment registrations | 1528319 |
| FEI numbers | 1000122656 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer |
| 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