Large UNI-Clip®
The straight drilling guide, positionned with the osteotomy centered between the two sleeves, is used to guide the drills while drilling the holes for the straight staples.
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 | Newdeal Sas, United States |
|---|---|
| FDA product code | HXJ |
| Device type | Staple Driver |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Premarket notification | Exempt |
| Record published | 2017-05-31 |
| Record revised | 2020-04-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2018-10-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 119324ND | 3.1mm inner/5mm outer diameter X 55mm length | Withdrawn |
| 119322ND | 3.1mm inner/5mm outer diameter X 50mm length | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| COGNiTiON™ Staple System | Ortho Solutions Inc | 6 |
| Inion FreedomPin Instruments | Inion OY | 4 |
| Inion Otps Pin Instruments | Inion OY | 2 |
| In2Bones | In2Bones SAS | 1 |
| Impactor Assembly | Xiros Ltd | 1 |
| Staple Driver | Smith & Nephew, Inc. | 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.