HandCut
10 CS - DISPOSABLE NEEDLE 16G x150mm FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION
5manufacturers in China registered for this device type
22catalogue 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 | M.D.L. S.R.L., Italy |
|---|---|
| FDA product code | MJG |
| Device type | Device, Percutaneous, Biopsy |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-14 |
| Record revised | 2021-05-27 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Sizes | Needle gauge 14 to 18 G; length 74 to 150 mm |
| Distribution end date | 2021-05-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM1610 | Length 100 mm | In distribution |
| PM1415 | Length 150 mm | In distribution |
| PM16075 | Length 75 mm | In distribution |
| PM16114 | Length 114 mm | In distribution |
| PM14114 | Needle Gauge 14 G | In distribution |
| PM1410 | Needle Gauge 14 G | In distribution |
| PM18075 | Length 75 mm | In distribution |
| PM14074 | Needle Gauge 14 G | In distribution |
| PM18114 | Length 114 mm | In distribution |
| PM1815 | Length 150 mm | In distribution |
| PM1615 | Length 150 mm | In distribution |
| PM1815 | Length 150 mm | Withdrawn |
| PM16114 | Length 114 mm | Withdrawn |
| PM18114 | Length 114 mm | Withdrawn |
| PM14114 | Needle Gauge 14 G | Withdrawn |
| PM1615 | Length 150 mm | Withdrawn |
| PM14074 | Needle Gauge 14 G | Withdrawn |
| PM1415 | Length 150 mm | Withdrawn |
| PM1410 | Withdrawn | |
| PM18075 | Length 75 mm | Withdrawn |
| PM16075 | Length 75 mm | Withdrawn |
| PM1610 | Withdrawn |
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 |
| 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 | Closed |
|---|---|---|---|---|---|
| 2021-08-05 | Class II | Other | Sterility assurance may be compromised. | 4120 units | 2026-05-04 |
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.