Staple Driver
Extension ROD Staple Driver-Extractor
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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HXJ |
| Device type | Staple Driver |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2015-08-25 |
| Record revised | 2024-09-11 (version 9) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 111129 | In distribution |
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 |
| Large UNI-Clip® | Newdeal Sas | 2 |
| In2Bones | In2Bones SAS | 1 |
| Impactor Assembly | Xiros Ltd | 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.