MammoStar™
Biopsy Site Identifier - Revolve
1manufacturer
15catalogue 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 | Carbon Medical Technologies, Inc., United States |
|---|---|
| FDA product code | NEU |
| Device type | Marker, Radiographic, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2015-09-24 |
| Record revised | 2023-09-18 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| 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 60 to 90 °F |
| Packaging | Carton of 10 |
| Sizes | Length 9 to 17 mm; outer diameter 2 mm; needle gauge 10 to 14 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| STAR1101 | Length 17 mm | In distribution |
| STAR0832 | Length 17 mm | In distribution |
| STAR0833 | Length 9 mm | In distribution |
| STAR1033 | Length 9 mm | In distribution |
| STAR1121 | Biopsy Probe Inner Diameter; 3.1 millimeter | In distribution |
| STAR0802 | Outer Diameter 2 mm | In distribution |
| STAR0831 | Length 17 mm | In distribution |
| STAR1001 | Length 17 mm | In distribution |
| STAR1402 | Length 17 mm | In distribution |
| STAR1102 | Length 17 mm | In distribution |
| STAR1403 | Length 9 mm | In distribution |
| STAR0801 | Biopsy Probe Inner Diameter; 4.3 millimeter | In distribution |
| STAR1401 | Length 17 mm | In distribution |
| STAR1032 | Length 17 mm | In distribution |
| STAR1031 | Length 17 mm | 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 |
| SecurMark for Atec | Hologic, Inc. | 15 |
| SenoMark® Ultra Breast Tissue Marker | Bard Peripheral Vascular, Inc. | 14 |
| 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 |
|---|---|
| K251748 | 2025-07-23 |
| K132708 | 2013-12-20 |
| K100994 | 2010-04-30 |
| K070436 | 2007-03-16 |
| K063193 | 2006-11-21 |
| K042296 | 2004-09-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Carbon Medical Technologies, Inc. | UDI-DI | 2022-12-16 | Class II | Under Investigation by firm | The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14 gauge needle, while the packaging contains STAR1402, a 1x5mm Tribell shaped marker pre-loaded in a 14 gauge needle. | 550 devices | 2023-08-09 |
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.