M-Biopsy Needle for Reusable Biopsy Instruments
The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an…
The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy® Biopsy Needle for a Bard® Magnum® or Pro-Mag™ Biopsy Instrument.
2manufacturers in China registered for this device type
55catalogue numbers in this listing
1recall
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 |
| Wenzhou Aochang Misawa Medical Tech. Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Mermaid Medical A/S, Denmark |
|---|---|
| FDA product code | DWO |
| Device type | Needle, Biopsy, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-08-05 |
| Record revised | 2023-10-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight and keep dry |
| Packaging | Retail box of 10 |
| Sizes | Needle gauge 14 to 20 G; length 10 to 30 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N20414016 | Needle Gauge 14 G | In distribution |
| N20114013 | Needle Gauge 14 G | In distribution |
| N20314010 | Needle Gauge 14 G | In distribution |
| N20120020 | Needle Gauge 20 G | In distribution |
| N20218025 | Needle Gauge 18 G | In distribution |
| N20320010 | Needle Gauge 20 G | In distribution |
| N20418013 | Needle Gauge 18 G | In distribution |
| N20318016 | Needle Gauge 18 G | In distribution |
| N20316016 | Needle Gauge 16 G | In distribution |
| N20314016 | Needle Gauge 14 G | In distribution |
| N20214016 | Needle Gauge 14 G | In distribution |
| N20118030 | Needle Gauge 18 G | In distribution |
| N20420020 | Needle Gauge 20 G | In distribution |
| N20214020 | Needle Gauge 14 G | In distribution |
| N20320016 | Needle Gauge 20 G | In distribution |
| N20216010 | Needle Gauge 16 G | In distribution |
| N20118016 | Needle Gauge 18 G | In distribution |
| N20218016 | Needle Gauge 18 G | In distribution |
| N20114020 | Needle Gauge 14 G | In distribution |
| N20120013 | Needle Gauge 20 G | In distribution |
| N20416016 | Needle Gauge 16 G | In distribution |
| N20114016 | Needle Gauge 14 G | In distribution |
| N20418020 | Needle Gauge 18 G | In distribution |
| N20318020 | Needle Gauge 18 G | In distribution |
| N20218030 | Needle Gauge 18 G | In distribution |
| N20116020 | Needle Gauge 16 G | In distribution |
| N20216016 | Needle Gauge 16 G | In distribution |
| N20214010 | Needle Gauge 14 G | In distribution |
| N20218010 | Needle Gauge 18 G | In distribution |
| N20220020 | Needle Gauge 20 G | In distribution |
| N20114010 | Needle Gauge 14 G | In distribution |
| N20420010 | Needle Gauge 20 G | In distribution |
| N20218020 | Needle Gauge 18 G | In distribution |
| N20220016 | Needle Gauge 20 G | In distribution |
| N20116013 | Needle Gauge 16 G | In distribution |
| N20118010 | Needle Gauge 18 G | In distribution |
| N20416010 | Needle Gauge 16 G | In distribution |
| N20420016 | Needle Gauge 20 G | In distribution |
| N20418016 | Needle Gauge 18 G | In distribution |
| N20118013 | Needle Gauge 18 G | In distribution |
| N20216020 | Needle Gauge 16 G | In distribution |
| N20118025 | Needle Gauge 18 G | In distribution |
| N20214012 | Needle Gauge 14 G | In distribution |
| N20220010 | Needle Gauge 20 G | In distribution |
| N20120016 | Needle Gauge 20 G | In distribution |
| N20320020 | Needle Gauge 20 G | In distribution |
| N20118020 | Needle Gauge 18 G | In distribution |
| N20318010 | Needle Gauge 18 G | In distribution |
| N20414010 | Needle Gauge 14 G | In distribution |
| N20116010 | Needle Gauge 16 G | In distribution |
| N20316010 | Needle Gauge 16 G | In distribution |
| N20120010 | Needle Gauge 20 G | In distribution |
| N20116016 | Needle Gauge 16 G | In distribution |
| N20420013 | Needle Gauge 20 G | In distribution |
| N20418010 | Needle Gauge 18 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biocore II MG | Histo S.A. | 33 |
| Biocore II TC | Histo S.A. | 26 |
| UltraCore™ Biopsy Needle | Argon Medical Devices, Inc. | 18 |
| Illy | M.D.L. S.R.L. | 16 |
| Biocore II BR | Histo S.A. | 15 |
| PenBone | M.D.L. S.R.L. | 14 |
| Biocore II | Histo S.A. | 14 |
| PickUp | M.D.L. S.R.L. | 12 |
| Custom Healthcare Systems, Inc. | Manus Medical, LLC | 11 |
| PressTo | M.D.L. S.R.L. | 10 |
| OsteoJ | M.D.L. S.R.L. | 10 |
| Mamawire Plus | Histo S.A. | 6 |
Showing 12 of 28. All products under Needle, Biopsy, Cardiovascular
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 |
|---|---|---|---|---|---|
| 2015-06-15 | Class II | Process control | Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula. | 320 | 2015-12-07 |
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.