Kyphon Bone Biopsy Kit
Bone Biopsy F18A Kyphx Bone Biopsy KIT
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Tianjin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Tianjin Newtrans Technology Development | Tianjin | Tianjin | Exporter | 11 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Medtronic Sofamor Danek, Inc., United States |
|---|---|
| FDA product code | MJG |
| Device type | Device, Percutaneous, Biopsy |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2018-12-21 |
| Record revised | 2022-12-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Store in a cool, dry place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F18A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 392 |
| Cook | Cook Incorporated | 77 |
| Intro | M.D.L. S.R.L. | 34 |
| Franseen | Cook Incorporated | 32 |
| HandCut | M.D.L. S.R.L. | 22 |
| Turner | Cook Incorporated | 15 |
| Palium Needle | M.D.L. S.R.L. | 14 |
| Primocut | Pajunk Gmbh Medizintechnologie | 13 |
| FastCutP | M.D.L. S.R.L. | 10 |
| Co-Axial Cannula Bundle | Argon Medical Devices, Inc. | 10 |
| Medline Industries, Inc. | Medline Industries, Inc. | 10 |
| Greene | Cook Incorporated | 10 |
Showing 12 of 44. All products under Device, Percutaneous, Biopsy
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.