Mamawire
Breast pre - quirurgical breast localization needles
2manufacturers in China registered for this device type
6catalogue numbers in this listing
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 | Histo S.A., Argentina |
|---|---|
| FDA product code | DWO |
| Device type | Needle, Biopsy, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment humidity 15 to 85 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment temperature 10 to 40 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20 Ga x 5 cm | In distribution | |
| 20 Ga x 13 cm | In distribution | |
| 20 Ga x 10 cm | In distribution | |
| 20 Ga x 7 cm | In distribution | |
| 20 Ga x 12 cm | In distribution | |
| 20 Ga x 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
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.