StarchMark® Breast Tissue Marker
STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"
1manufacturer
3catalogue numbers in this listing
7510(k) clearances naming this product 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 | Senorx, Inc., United States |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| 510(k) | K131654 |
| Record published | 2015-10-02 |
| Record revised | 2024-04-17 (version 6) |
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 |
| Packaging | Case of 10 |
| Sizes | Needle gauge 7 to 11 G |
| Distribution end date | 2022-10-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STMKMT11GSS | Needle Gauge 11 G | Withdrawn |
| STMKEC7GSS | Needle Gauge 7 G | Withdrawn |
| STMKEC10GSS | Needle Gauge 10 G | Withdrawn |
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 |
|---|---|
| K131654 | 2013-06-27 |
| K081085 | 2008-08-01 |
| K081170 | 2008-05-28 |
| K080698 | 2008-03-31 |
| K050090 | 2005-02-07 |
| K040706 | 2004-04-08 |
| K031938 | 2003-09-05 |
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.