| Primary Device ID | 15420045506497 |
| NIH Device Record Key | 91b62d58-a761-4dd5-9c82-78e0d7058f4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Affirm Prone Biopsy System |
| Version Model Number | ASY-08178 |
| Catalog Number | ASY-08178 |
| 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 |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com | |
| Phone | +1(800)442-9892 |
| CustomerSupport@hologic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15420045506497 [Primary] |
| GS1 | 25420045506494 [Package] Package: BAG [1 Units] In Commercial Distribution |
| IZH | System, x-ray, mammographic |
| 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 | 2016-12-02 |
| 15420045506541 | ASY-09175 |
| 15420045506534 | ASY-08832 |
| 15420045506527 | ASY-06886 |
| 15420045506510 | PBX-SYS-AFFIRM-3D |
| 15420045506503 | PBX-SYS-AFFIRM-2D |
| 15420045506497 | ASY-08178 |
| 15420045506480 | ASY-08176 |
| 15420045506473 | ASY-08175 |
| 15420045506466 | ASY-08174 |
| 15420045504738 | 3D System Software |
| 15420045504721 | System Software |
| 15420045510869 | PBX-SYS-AFFIRM-2D |
| 15420045510852 | PBX-SYS-AFFIRM-2D |
| 15420045510845 | PBX-SYS-AFFIRM-2D |