Tumark® Vision for Eviva® Standard
2 catalogue numbers from TUMARK-E13-S-V-02, listed by Somatex Medical Technologies GmbH, Germany, under Marker, Radiographic, Implantable. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Somatex Medical Technologies GmbH, Germany |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2023-08-28 |
| 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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TUMARK-E13-S-V-02 | In distribution | |
| Tumark-E13-S-Vision | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HydroMARK | Devicor Medical Products, Inc. | 75 |
| Scout® | Merit Medical Systems, Inc. | 68 |
| Scout MD™ | Merit Medical Systems, Inc. | 46 |
| SmartClip | Elucent Medical Inc. | 37 |
| BiomarC® | Carbon Medical Technologies, Inc. | 25 |
| HydroMARK Breast Biopsy Site Marker | Devicor Medical Products, Inc. | 21 |
| SecurMark | Hologic, Inc. | 15 |
| Gold Marker | Riverpoint Medical LLC | 15 |
| MammoStar™ | Carbon Medical Technologies, Inc. | 15 |
| SecurMark for Atec | Hologic, Inc. | 15 |
| SenoMark® Ultra Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 14 |
| TriMark | Hologic, Inc. | 14 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201863 | 2021-02-18 |
| K182082 | 2018-10-31 |
| K180443 | 2018-03-22 |
| K111692 | 2011-11-08 |
| K093064 | 2010-02-17 |
| K073095 | 2008-03-19 |
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 | Closed |
|---|---|---|---|---|
| 2017-05-22 | Class II | Device Design | There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile. | 2018-08-30 |
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.