Primary Device ID | 15420045505322 |
NIH Device Record Key | ff4d70ae-6aad-4264-8394-bb789c5d1eb6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EVIVA 0913-12 |
Version Model Number | EVIVA 0913-12 |
Catalog Number | EVIVA 0913-12 |
Company DUNS | 018925968 |
Company Name | Hologic, Inc. |
Device Count | 1 |
DM Exempt | true |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 | 15420045505322 [Primary] |
GS1 | 25420045505329 [Package] Package: TRAY [5 Units] In Commercial Distribution |
GS1 | 35420045505326 [Package] Package: TRAY [5 Units] In Commercial Distribution |
KNW | INSTRUMENT, BIOPSY |
Steralize Prior To Use | true |
Device Is Sterile | false |
[15420045505322]
Radiation Sterilization
[15420045505322]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2018-07-12 |
Device Publish Date | 2016-07-26 |
15420045517097 - DIGITAL DIAGNOSTICS SYSTEM | 2025-07-25 Computer to operate the Genius™ Review Station. |
15420045517851 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and |
15420045517882 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and |
15420045517899 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system generates digital mammographic images that can be used for screening and |
15420045517905 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b |
15420045517912 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b |
15420045517929 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b |
15420045517936 - Selenia® Dimensions® | 2025-07-25 The Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the b |