PaliumNeedle
10CS-DISP.NEEDLE 14GX100mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITH BARD AUTOM. MAGNUM GUN/PALIUM GUN
5manufacturers in China registered for this device type
10catalogue 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 | 2017-01-05 |
| 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 12 to 18 G; length 100 to 250 mm |
| Distribution end date | 2021-05-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MGK11820 | Needle Gauge 18 G | Withdrawn |
| MGK11413 | Length 130 mm | Withdrawn |
| MGK11616 | Length 160 mm | Withdrawn |
| MGK11410 | Needle Gauge 14 G | Withdrawn |
| MGK11825 | Length 250 mm | Withdrawn |
| MGK11610 | Needle Gauge 16 G | Withdrawn |
| MGK11810 | Needle Gauge 18 G | Withdrawn |
| MGK11210 | Length 100 mm | Withdrawn |
| MGK11816 | Length 160 mm | Withdrawn |
| MGK11620 | Needle Gauge 16 G | Withdrawn |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 |
| 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
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.