Arthrex®
C Mount, Optical Coupler, 19.7 EFL
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
Record
| Listed by | Arthrex, Inc., United States |
|---|---|
| FDA product code | FEI |
| Device type | Instrument, Special Lens, For Endoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-07-07 |
| Record revised | 2024-09-23 (version 3) |
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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AR-3210-0012 | In distribution | |
| AR-3210-0005 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Special Lens, For Endoscope | Smith & Nephew, Inc. | 22 |
| Zoom coupler Arthrex 14-29mm C-Mount | W.O.M. World of Medicine GmbH | 1 |
| Intelijet | Smith & Nephew, Inc. | 1 |
| gastroduodenal Ftrd prOVE Cap | Ovesco Endoscopy AG | 1 |
| Ftrd prOVE Cap | Ovesco Endoscopy AG | 1 |
| colonic Ftrd prOVE Cap | Ovesco Endoscopy AG | 1 |
| Autoclavable HD-Zoom Coupler | W.O.M. World of Medicine GmbH | 1 |
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.