Gsource
K-Wire D. Trocar 5" 0.7mm [.028"] pkg/6
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
Record
| Listed by | Gsource, LLC., United States |
|---|---|
| FDA product code | KDW |
| Device type | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3250 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K100736 |
| Record published | 2017-03-31 |
| Record revised | 2024-02-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 78.2050 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Skin Biopsy Transport Kit | Vericel Corporation | 2 |
| Cartilage Biopsy Transport Kit | Vericel Corporation | 2 |
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.