miniARM® LOCKING COUPLER - For use with the Olympus® ENDOEYE FLEX® 5mm HD surgical video camera (LTF-S190-5) (NOTE: the miniARM® Locking Coupler requires either 1) the miniARM® Cannula…
miniARM® LOCKING COUPLER – For use with the Olympus® ENDOEYE FLEX® 5mm HD surgical video camera (LTF-S190-5) (NOTE: the miniARM® Locking Coupler requires either 1) the miniARM® Cannula Adapter Kit (#080415) OR 2) the miniARM® Clamping Adapter (#080519) in order to be attached to the miniARM® Instrument Holder)
Who Else Makes It
Registered in Jiangsu.
Record
Regulatory record for miniARM® multiSTATION™ System | Listed by | LSI Solutions Inc., United States |
| FDA product code | FXR |
| Device type | Holder, Camera, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-13 |
| Record revised | 2022-11-10 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.