FDA device listing
3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE),Caviwave Ultrasonic Cleaner (MD-CFE),Distal Duck Kit (MD-CFE),Distal…
FDA device listing 1095089287 · STERIS Corporation
Key facts
| Proprietary names | 3E-ZYME Triple Enzyme Cleaning Solution (SL-CFE),Caviwave Ultrasonic Cleaner (MD-CFE),Distal Duck Kit (MD-CFE),Distal Tip Soakers (MD-CFE),InnoWave ECO 2.6 Gallon Standard Mesh Basket (MD-MF),InnoWave ECO 5.3 Gallon Standard Mesh Basket (MD-MF),InnoWave ECO ULTRASONIC CLEANER (2.6 GAL) (MD-MF),InnoWave ECO ULTRASONIC CLEANER (5.3 GAL) (MD-MF),InnoWave ULTRA SONIC IRRIGATOR (MD-MF),InnoWave ULTRA+… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10078069 |
| Product codes | FLG |
| Device names | FLG - Cleaner, Ultrasonic, Medical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6150 |
| Review panels | General Hospital |
| Registered establishments | ALBERT BROWNE LTD., MEDISAFE UK LTD., STERIS CORPORATION, UNITED STATES ENDOSCOPY GROUP, INC. |
| Establishment registrations | 1528319, 1933443, 1937531, 8021896, 9617134 |
| FEI numbers | 1937531, 1000122656, 1000510740, 3000255542, 3001168737 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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