Cook
Coaxial Disposable Franseen Biopsy Needle
5manufacturers in China registered for this device type
77catalogue numbers in this listing
1recall
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | MJG |
| Device type | Device, Percutaneous, Biopsy |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
| Record revised | 2022-05-20 (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, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2022-05-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G00014 | In distribution | |
| G03955 | In distribution | |
| G02381 | In distribution | |
| G07250 | In distribution | |
| G01104 | In distribution | |
| G00777 | In distribution | |
| G06987 | In distribution | |
| G00776 | In distribution | |
| G00016 | In distribution | |
| G04144 | In distribution | |
| G08080 | In distribution | |
| G00015 | In distribution | |
| G02585 | In distribution | |
| G00850 | In distribution | |
| G08038 | In distribution | |
| G07114 | In distribution | |
| G27322 | In distribution | |
| G19415 | In distribution | |
| G01133 | In distribution | |
| G00778 | In distribution | |
| G00895 | In distribution | |
| G01427 | In distribution | |
| G03020 | In distribution | |
| G01559 | In distribution | |
| G03992 | In distribution | |
| G01746 | In distribution | |
| G04736 | In distribution | |
| G27323 | In distribution | |
| G01597 | In distribution | |
| G03314 | In distribution | |
| G27317 | In distribution | |
| G27311 | In distribution | |
| G04647 | In distribution | |
| G05147 | In distribution | |
| G00810 | In distribution | |
| G01047 | In distribution | |
| G05040 | In distribution | |
| G05848 | In distribution | |
| G07307 | In distribution | |
| G04338 | In distribution | |
| G00896 | In distribution | |
| G01040 | In distribution | |
| G19417 | In distribution | |
| G06619 | In distribution | |
| G00886 | In distribution | |
| G19416 | In distribution | |
| G07986 | In distribution | |
| G12816 | In distribution | |
| G27400 | In distribution | |
| G09427 | In distribution | |
| G04834 | In distribution | |
| G03954 | In distribution | |
| G00933 | In distribution | |
| G08101 | In distribution | |
| G00013 | In distribution | |
| G00852 | In distribution | |
| G10073 | In distribution | |
| G07115 | In distribution | |
| G04637 | In distribution | |
| G27407 | In distribution | |
| G03978 | In distribution | |
| G04586 | In distribution | |
| G02419 | In distribution | |
| G00831 | In distribution | |
| G26959 | In distribution | |
| G00012 | In distribution | |
| G27394 | In distribution | |
| G04512 | In distribution | |
| G10714 | In distribution | |
| G01112 | In distribution | |
| G09119 | In distribution | |
| G07120 | In distribution | |
| G00934 | In distribution | |
| G02986 | In distribution | |
| G02606 | In distribution | |
| G08079 | In distribution | |
| G05502 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 392 |
| 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 |
| PaliumNeedle | M.D.L. S.R.L. | 10 |
Showing 12 of 44. All products under Device, Percutaneous, Biopsy
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-03-01 | Class II | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility | 6,178 units |
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.