Biopsybell SRL
Needle FOR Bone Marrow Explant
3manufacturers in China registered for this device type
130catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Biopsybell SRL |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| 510(k) | K130616 |
| Record published | 2023-10-23 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Blister of 5 |
| Sizes | Needle gauge 7 to 18 G; length 13.5 to 170 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UNLUX SYSTEM | Needle Gauge 13 G | In distribution |
| ORION EXPLANT | Needle Gauge 11 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 08 G | In distribution |
| ORION | Needle Gauge 15 G | In distribution |
| OBSTERN | Needle Gauge 11 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 15 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 14 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 13 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 14 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 18 G | In distribution |
| STERNOBELL | Needle Gauge 14 G | In distribution |
| OBSTERN | Needle Gauge 13 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 13 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 13 G | In distribution |
| OBSTERN | Needle Gauge 14 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 13 G | In distribution |
| STERNOBELL | Needle Gauge 13 G | In distribution |
| OBSTERN | Needle Gauge 16 G | In distribution |
| ORION EXPLANT | Needle Gauge 13 G | In distribution |
| STERNOBELL | Needle Gauge 18 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 13 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 11 G | In distribution |
| OBSTERN | Needle Gauge 16 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 11 G | In distribution |
| ORION EXPLANT | Needle Gauge 13 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 11 G | In distribution |
| ORION EXPLANT | Needle Gauge 15 G | In distribution |
| ORION | Needle Gauge 16 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 07 G | In distribution |
| ORION | Needle Gauge 10 G | In distribution |
| STERNOBELL | Needle Gauge 18 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 11 G | In distribution |
| OBSTERN | Needle Gauge 13 G | In distribution |
| UNLUX SYSTEM | Needle Gauge 08 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 13 G | In distribution |
| ORION | Needle Gauge 14 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 11 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 09 G | In distribution |
| UNLUX SYSTEM | Needle Gauge 11 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 18 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 13 G | In distribution |
| STERNOBELL | Needle Gauge 14 G | In distribution |
| STERNOBELL | Needle Gauge 15 G | In distribution |
| UNLUX SYSTEM | Needle Gauge 07 G | In distribution |
| STERNOBELL | Needle Gauge 14 G | In distribution |
| OBSTERN | Needle Gauge 15 G | In distribution |
| ORION EXPLANT | Needle Gauge 14 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 11 G | In distribution |
| OBSTERN | Needle Gauge 13 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 07 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 16 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 11 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 11 G | In distribution |
| ORION EXPLANT | Needle Gauge 11 G | In distribution |
| ORION | Needle Gauge 18 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 08 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 11 G | In distribution |
| OBSTERN | Needle Gauge 16 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 14 G | In distribution |
| ORION | Needle Gauge 15 G | In distribution |
| STERNOBELL | Needle Gauge 13 G | In distribution |
| OBSTERN | Needle Gauge 14 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 13 G | In distribution |
| UNLUX SYSTEM | Needle Gauge 08 G | In distribution |
| STERNOBELL | Needle Gauge 15 G | In distribution |
| OBSTERN | Needle Gauge 15 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 09 G | In distribution |
| OBSTERN | Needle Gauge 11 G | In distribution |
| OBSTERN | Needle Gauge 18 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 18 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 13 G | In distribution |
| STERNOBELL | Needle Gauge 16 G | In distribution |
| STERNOBELL | Needle Gauge 16 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 14 G | In distribution |
| STERNOBELL | Needle Gauge 18 G | In distribution |
| OBSTERN | Needle Gauge 18 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 09 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 11 G | In distribution |
| UNLUX SYSTEM | Needle Gauge 07 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 15 G | In distribution |
| UNLUX SYSTEM | Needle Gauge 09 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 14 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 15 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 13 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 09 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 15 G | In distribution |
| OBSTERN | Needle Gauge 18 G | In distribution |
| OBSTERN | Needle Gauge 15 G | In distribution |
| ORION | Needle Gauge 16 G | In distribution |
| ORION | Needle Gauge 13 G | In distribution |
| UNLUX SYSTEM | Needle Gauge 11 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 13 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 16 G | In distribution |
| STERNOBELL | Needle Gauge 13 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 13 G | In distribution |
| ORION EXPLANT | Needle Gauge 15 G | In distribution |
| STERNOBELL | Needle Gauge 15 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 13 G | In distribution |
| ORION | Needle Gauge 18 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 15 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 07 G | In distribution |
| OBSTERN | Needle Gauge 13 G | In distribution |
| ORION | Needle Gauge 14 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 15 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 11 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 08 G | In distribution |
| OSTEOBELL EXPLANT | Needle Gauge 15 G | In distribution |
| ORION EXPLANT | Needle Gauge 15 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 18 G | In distribution |
| STERNOBELL | Needle Gauge 16 G | In distribution |
| ORION | Needle Gauge 10 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 15 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 11 G | In distribution |
| TOTALLY REMOVE | Needle Gauge 08 G | In distribution |
| ORION EXPLANT | Needle Gauge 13 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 13 G | In distribution |
| ORION | Needle Gauge 16 G | In distribution |
| UNLUX SYSTEM | Needle Gauge 13 G | In distribution |
| ORION EXPLANT | Needle Gauge 14 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 14 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 16 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 15 G | In distribution |
| OBSTERN | Needle Gauge 14 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 07 G | In distribution |
| OBSTERN EXPLANT | Needle Gauge 15 G | In distribution |
| ORION EXPLANT | Needle Gauge 14 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 16 G | In distribution |
| OSTEOBELL “T” | Needle Gauge 11 G | In distribution |
| STERNOBELL EXPLANT | Needle Gauge 13 G | In distribution |
| ORION | Needle Gauge 15 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 227 |
| Medline Industries, Inc. | Medline Industries, Inc. | 98 |
| Themy | M.D.L. S.R.L. | 61 |
| SemiCut | M.D.L. S.R.L. | 46 |
| Temno® | Merit Medical Systems, Inc. | 37 |
| Temno | Carefusion 2200, Inc. | 36 |
| CorVocet™ | Merit Medical Systems, Inc. | 34 |
| Truguide | Bard Peripheral Vascular, Inc. | 31 |
| Temno Evolution® | Merit Medical Systems, Inc. | 28 |
| ClearTip | Finemedix | 25 |
| Magnum | Bard Peripheral Vascular, Inc. | 22 |
| SemiCut Coax. | M.D.L. S.R.L. | 22 |
Showing 12 of 115. All products under Biopsy Needle
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Biopsybell S.R.L. | 510(k) number | 2021-03-22 | Class II | Vendor change control | Products labeled as sterile were distributed, but may not have been sterilized. | 50 units | 2026-02-17 |
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.