Primary Device ID | 15420045512689 |
NIH Device Record Key | dfe03ba8-d3e3-4722-b9a1-31def80765ac |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | UNIFI™ IMAGE QUALITY ASSIST SOFTWARE |
Version Model Number | UNIFI IMAGE QUALITY ASSIST MOTION |
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 | 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 | 15420045512689 [Primary] |
OTE | Digital breast tomosynthesis |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-10 |
Device Publish Date | 2021-06-02 |
15420045512696 | UNIFI IMAGE QUALITY ASSIST POSITIONING |
15420045512689 | UNIFI IMAGE QUALITY ASSIST MOTION |