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OnControl® Bone Marrow Biopsy System Comprehensive Tray, 102mm
3manufacturers in China registered for this device type
17catalogue 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | FCG |
| Device type | Biopsy Needle |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K142377 |
| Record published | 2016-09-16 |
| Record revised | 2025-02-07 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store between 15 – 30C (59 – 86F). |
| Packaging | Carton of 6, box of 6, case of 5, carton of 20 |
| Sizes | Length 25 to 152 mm; needle gauge 11 to 15 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN033817 | Length 90 mm | In distribution |
| IPN033788 | Length 25 mm | In distribution |
| IPN033813 | Length 68 mm | In distribution |
| IPN033778 | In distribution | |
| IPN033776 | Length 152 mm | In distribution |
| IPN033786 | In distribution | |
| IPN928632 | In distribution | |
| IPN033782 | In distribution | |
| IPN033793 | In distribution | |
| IPN033792 | In distribution | |
| IPN928370 | In distribution | |
| IPN033816 | In distribution | |
| IPN930080 | In distribution | |
| IPN033784 | Length 102 mm | In distribution |
| IPN033774 | In distribution | |
| IPN033815 | In distribution | |
| IPN928869 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 227 |
| Biopsybell SRL | Biopsybell SRL | 130 |
| 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 |
Showing 12 of 115. All products under Biopsy Needle
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.