PenBone
DISPOSABLE BONE BIOPSY NEEDLE FOR ILIAC CREST MARROW ASPIRATION, LIGHT VERSION 15G X 35/100 mm
2manufacturers in China registered for this device type
14catalogue 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 | M.D.L. S.R.L., Italy |
|---|---|
| FDA product code | DWO |
| Device type | Needle, Biopsy, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-04-13 |
| Record revised | 2021-05-27 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Sizes | Needle gauge 14 to 18 G |
| Distribution end date | 2021-05-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PI1510/75 | Needle Gauge 15 G | In distribution |
| PI1535/100 | Needle Gauge 15 G | In distribution |
| PI1610/75 | Needle Gauge 16 G | In distribution |
| PI1810/75 | Needle Gauge 18 G | In distribution |
| PIP1530/70 | Needle Gauge 15 G | Withdrawn |
| PI1535/100 | Withdrawn | |
| PIP1410/50 | Needle Gauge 14 G | Withdrawn |
| PIP1630/70 | Needle Gauge 16 G | Withdrawn |
| PI1810/75 | Withdrawn | |
| PIP1430/70 | Needle Gauge 14 G | Withdrawn |
| PI1610/75 | Withdrawn | |
| PIP1510/50 | Needle Gauge 15 G | Withdrawn |
| PIP1830/70 | Needle Gauge 18 G | Withdrawn |
| PI1510/75 | Withdrawn |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 |
| UltraCore™ Biopsy Needle | Argon Medical Devices, Inc. | 18 |
| Illy | M.D.L. S.R.L. | 16 |
| Biocore II BR | Histo S.A. | 15 |
| 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 |
|---|---|---|---|---|---|
| 2021-08-05 | Class II | Other | Sterility assurance may be compromised. | 21,518 units | 2026-05-04 |
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.