| Primary Device ID | 15420045518278 |
| NIH Device Record Key | 6e99bf1a-6a4c-4b2f-a624-0d3503490a0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affirm Prone Biopsy System |
| Version Model Number | ASY-06886-CN |
| Catalog Number | ASY-06886-CN |
| Company DUNS | 964430230 |
| Company Name | Hologic, 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |