| Primary Device ID | 15420045507579 |
| NIH Device Record Key | 0c98cd1c-0018-43ca-bc2b-a06a5785deff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Selenia FFDM |
| Version Model Number | FAB-00610 |
| Company DUNS | 139534114 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045507579 [Primary] |
| MUE | Full field digital,system,x-ray,mammographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-23 |
| 15420045507920 | 4-000-0308 |
| 15420045507913 | ASY-05468 |
| 15420045507890 | 4-000-0144 |
| 15420045507883 | 3-000-4617 |
| 15420045507876 | 3-000-1528 |
| 15420045507715 | FAB-00752 |
| 15420045507708 | FAB-00609 |
| 15420045507692 | 4-000-0293 |
| 15420045507685 | 3-535-0087 |
| 15420045507678 | 3-535-0012 |
| 15420045507586 | FAB-00754 |
| 15420045507579 | FAB-00610 |
| 15420045507562 | FAB-00608 |
| 15420045507555 | 5-000-0073 |
| 15420045507548 | 5-000-0072 |
| 15420045506060 | ASY-07973 |
| 15420045506053 | ASY-06758 |
| 15420045506046 | ASY-06755 |
| 15420045506039 | ASY-06754 |
| 15420045506022 | ASY-06753 |
| 15420045506015 | ASY-06717 |
| 15420045506008 | ASY-06716 |
| 15420045505995 | ASY-06715 |
| 15420045505988 | ASY-06714 |
| 15420045505971 | ASY-01656 |
| 15420045505964 | ASY-01427 |
| 15420045505957 | ASY-01366 |
| 15420045505940 | ASY-00676 |
| 15420045505933 | ASY-00834 |