SenoMark® Ultra Breast Tissue Marker
SENOMARK® ULTRA Breast Tissue Marker, 11 Ga Mammotome, Titanium Ribbon
1manufacturer
14catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
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 | Bard Peripheral Vascular, Inc., United States |
|---|---|
| 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 |
| 510(k) | K123911 |
| Record published | 2015-10-01 |
| Record revised | 2023-09-18 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature up to 25 °C |
| Packaging | Case of 10 |
| Sizes | Needle gauge 7 to 12 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMAT12R | Needle Gauge 12 G | In distribution |
| SMMA11C | Needle Gauge 11 G | In distribution |
| SMAT12C | Needle Gauge 12 G | In distribution |
| SMEC7C | Needle Gauge 7 G | In distribution |
| SMAT9C | Needle Gauge 9 G | In distribution |
| SMEV9R | Needle Gauge 9 G | In distribution |
| SMEV9C | Needle Gauge 9 G | In distribution |
| SMMA11R | Needle Gauge 11 G | In distribution |
| SMAT9R | Needle Gauge 9 G | In distribution |
| SMEC12C | Needle Gauge 12 G | In distribution |
| SMEC12R | Needle Gauge 12 G | In distribution |
| SMEC7R | Needle Gauge 7 G | In distribution |
| SMEC10R | Needle Gauge 10 G | In distribution |
| SMEC10C | Needle Gauge 10 G | 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 |
| TriMark | Hologic, Inc. | 14 |
| Mammotome revolve MammoMark | Devicor Medical Products, Inc. | 10 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K243642 | 2025-03-24 |
| K180061 | 2018-03-09 |
| K152510 | 2016-05-13 |
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2013-01-23 | Class II | Process control | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker’s and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the s | 315 | 2013-06-10 |
| 2013-01-23 | Class II | Process control | Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual Trigger Tissue Marker’s and support catheters (Microsheath and Usher) were inadvertently distributed to customers without completing the s | 815 | 2013-06-10 |
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.