Lung Marker System
2 catalogue numbers from 272015, listed by Somatex Medical Technologies GmbH, Germany, under Needle, Tumor Localization. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Xiazhifeng Electronic Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 25 |
| Ningbo Hysent Medical Technology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 13 |
Record
| Listed by | Somatex Medical Technologies GmbH, Germany |
|---|---|
| FDA product code | MIJ |
| Device type | Needle, Tumor Localization |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-10-28 |
| Record revised | 2026-07-03 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
| Distribution end date | 2025-04-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 272015 | Withdrawn | |
| 272012 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kopans | Cook Incorporated | 27 |
| Medwire | Medax Srl Unipersonale | 22 |
| Sinurep | Medax Srl Unipersonale | 9 |
| ALM SET | H.S. Hospital Service SPA | 6 |
| Cook | Cook Incorporated | 5 |
| Tuflex | Somatex Medical Technologies GmbH | 4 |
| Breast Needle Locator | Remington Medical, Inc. | 4 |
| Q-Wire System | Somatex Medical Technologies GmbH | 3 |
| Tuloc Premium | Somatex Medical Technologies GmbH | 3 |
| Tuloc | Somatex Medical Technologies GmbH | 3 |
| Tuflex Premium | Somatex Medical Technologies GmbH | 3 |
| MRI Tuloc | Somatex Medical Technologies GmbH | 2 |
Showing 12 of 37. All products under Needle, Tumor Localization
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 |
|---|---|---|---|---|---|
| 2021-02-03 | Class II | Device Design | This recall has been initiated due to the risk of wire splintering after contact with a cautery device during the removal of a lesion. There is a potential risk that wire fragments are not removed during the procedure and stays inside the p | 196 pieces | 2022-01-13 |
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.