FDA device listing
Rover35148 (VL) - Rovers Anex Brush,Rover35148 (VL) - Rovers Evalyn Brush,SteriPack9541 (RB,DK,VL2) - Sterile Polyester…
FDA device listing 2055068640 · STERIS Corporation
Key facts
| Proprietary names | Rover35148 (VL) - Rovers Anex Brush,Rover35148 (VL) - Rovers Evalyn Brush,SteriPack9541 (RB,DK,VL2) - Sterile Polyester Spun Swab,SteripackPoland (RB,DK,VL2,) - Sterile Flocked Swab; Sterile Foam Swab; SteriPack Sterile Polyester Spun Swab and Swab |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10042227 |
| Product codes | KXG |
| Device names | KXG - Applicator, Absorbent Tipped, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6025 |
| Review panels | General Hospital |
| Registered establishments | ELECTRON BEAM SDN BHD, STERIS Schweiz AG, STERIS SPA, STERIS TOMOE (Thailand) Ltd., Synergy Health Ede BV, Synergy Health Radeberg GMBH, Synergy Health Sterilisation UK Ltd, Synergy Sterilisation Rawang (m) Sdn. Bhd. |
| Establishment registrations | 8043792, 3002806603, 3002807310, 3008102042, 3008252486, 3009337401, 3010132111, 3010155648, 3010175289, 3017616393, 3020976354 |
| FEI numbers | 3002806603, 3002807310, 3002808269, 3002924544, 3008252486, 3009337401, 3010132111, 3010155648, 3010175289, 3017616393, 3020976354 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 10–99 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