| Primary Device ID | 15420045500013 |
| NIH Device Record Key | f4470812-4894-4bef-9d8d-9aaaad9bce7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Selenia Dimensions 3D System |
| Version Model Number | 3D software |
| Company DUNS | 139534114 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 15420045500013 [Primary] |
| OTE | Digital breast tomosynthesis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2014-09-05 |
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