MPM Medical Supply (Private Label)
11 GA X 4" Double Diamond J-Type Bone Needle With 14 GA Extraction Cannula
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Manan Medical Products, Inc., United States |
|---|---|
| FDA product code | DWO |
| Device type | Needle, Biopsy, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| 510(k) | K890925 |
| Record published | 2017-01-12 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Tyvek pouches of 5, unit boxes of 50, unit boxes of 10, tyvek pouch of 6 |
| Sizes | Length 4 in; length 15 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BMNJ-MEC-1110 | Length 4 in | In distribution |
| TNL0815 | Length 15 cm | In distribution |
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 |
| 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 |
Showing 12 of 28. All products under Needle, Biopsy, Cardiovascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K890925 | 1989-04-11 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Argon Medical Devices, Inc. | 510(k) number | 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 |
| Argon Medical Devices, Inc. | 510(k) number | 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 |
| Argon Medical Devices, Inc. | 510(k) number | 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 |
| Argon Medical Devices, Inc. | 510(k) number | 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 |
| Argon Medical Devices, Inc. | 510(k) number | 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 |
| Argon Medical Devices, Inc. | 510(k) number | 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 |
| Argon Medical Devices, Inc. | 510(k) number | 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 |
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.