Colonic Ftrd prOVE Cap
FTRD application cap for verification of possible application of the colonic FTRD (accessability and ability to pull lesion into the cap).
1manufacturer
1catalogue number
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 | Ovesco Endoscopy AG, Germany |
|---|---|
| FDA product code | FEI |
| Device type | Instrument, Special Lens, For Endoscope |
| Device class | Class 1 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-03-08 |
| Record revised | 2019-10-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Folding box of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FTRD 14 | endoscope diameter 11.5-13.2 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Instrument, Special Lens, For Endoscope | Smith & Nephew, Inc. | 22 |
| Arthrex® | Arthrex, Inc. | 2 |
| 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 |
| 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.