Biocore II BR
Biopsy Needle Biocore II BR
2manufacturers in China registered for this device type
15catalogue 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 | 2024-05-15 |
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 |
|---|---|---|
| 14 Ga x 12 cm | In distribution | |
| 18 Ga x 30 cm | In distribution | |
| 18 Ga x 12 cm | In distribution | |
| 14 Ga x 20 cm | In distribution | |
| 18 Ga x 25 cm | In distribution | |
| 14 Ga x 15 cm | In distribution | |
| 18 Ga x 15 cm | In distribution | |
| 16 Ga x 12 cm | In distribution | |
| 16 Ga x 15 cm | In distribution | |
| 18 Ga x 10 cm | In distribution | |
| 18 Ga x 20 cm | In distribution | |
| 16 Ga x 20 cm | In distribution | |
| 14 Ga x 10 cm | In distribution | |
| 16 Ga x 10 cm | In distribution | |
| 16 Ga x 25 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 |
| 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
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.