| Primary Device ID | 10801741031844 |
| NIH Device Record Key | a6d4ba38-d18f-4603-a90e-b9cd6b838a1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gel Mark Ultra™ Breast Tissue Marker |
| Version Model Number | GMU11T |
| Catalog Number | GMU11T |
| Company DUNS | 043674543 |
| Company Name | SENORX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |
| Handling Environment Temperature | Between 0 and 25 Degrees Celsius |