UltraCore™ Biopsy Needle
UltraCore™ Biopsy Needle 16ga x 10cm
2manufacturers in China registered for this device type
18catalogue numbers in this listing
7recalls on this code
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 | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | DWO |
| Device type | Needle, Biopsy, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2022-07-14 |
| Record revised | 2026-05-11 (version 4) |
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: Keep dry and away from sunlight |
| Packaging | Box of 10 |
| Distribution end date | 2025-01-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 762616100 | 16ga x 10cm | In distribution |
| 762614160 | 14ga x 16cm | In distribution |
| 762618200 | 18ga x 20cm | In distribution |
| 762618130 | 18ga x 13cm | In distribution |
| 762618250 | 18ga x 25cm | In distribution |
| 762618100 | 18ga x 10cm | In distribution |
| 762616200 | 16ga x 20cm | In distribution |
| 762616160 | 16ga x 16cm | In distribution |
| 762618160 | 18ga x 16cm | In distribution |
| 762618300 | 18ga x 30cm | In distribution |
| 762616130 | 16ga x 13cm | In distribution |
| 762614100 | 14ga x 10cm | In distribution |
| 762614130 | 14ga x 13cm | In distribution |
| 762620100 | 20ga x 10cm | Withdrawn |
| 762614200 | 14ga x 20cm | Withdrawn |
| 762620200 | 20ga x 20cm | Withdrawn |
| 762620160 | 20ga x 16cm | Withdrawn |
| 762620130 | 20ga x 13cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| M-Biopsy Needle For Reusable Biopsy Instruments | Mermaid Medical A/S | 55 |
| Biocore II MG | Histo S.A. | 33 |
| Biocore II TC | Histo S.A. | 26 |
| 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
7 of these are 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 |
|---|---|---|---|---|---|
| 2018-12-18 | Class II | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line | 9,900 units | 2020-08-23 |
| 2018-12-18 | Class II | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line | 500 units | 2020-08-23 |
| 2018-12-18 | Class II | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line | 1,404 units | 2020-08-23 |
| 2018-12-18 | Class II | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line | 504 units | 2020-08-23 |
| 2018-12-18 | Class II | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line | 1,260 units | 2020-08-23 |
| 2018-12-18 | Class II | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line | 2,502 units | 2020-08-23 |
| 2018-12-18 | Class II | Equipment maintenance | Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line | 180 units | 2020-08-23 |
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.