Gold Marker
15 catalogue numbers from GM1054, listed by Riverpoint Medical LLC, United States, under Marker, Radiographic, Implantable. 1 manufacturer in China is registered for this product code.
1manufacturer
15catalogue numbers in this listing
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 | Riverpoint Medical LLC, 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 |
| 510(k) | K103449 |
| Record published | 2016-02-01 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 9, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GM1054 | In distribution | |
| GM0833 | In distribution | |
| GM1233 | In distribution | |
| GM-123 | In distribution | |
| GM1052 | In distribution | |
| GM1032 | In distribution | |
| GM1251 | In distribution | |
| GM0851 | In distribution | |
| GM0855 | In distribution | |
| GM0834 | In distribution | |
| GM-1033 | In distribution | |
| GM1033K | In distribution | |
| GM1053 | In distribution | |
| GM1254 | In distribution | |
| GM1033 | 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 |
| 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 |
| Mammotome revolve MammoMark | Devicor Medical Products, Inc. | 10 |
Showing 12 of 96. All products under Marker, Radiographic, Implantable
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.