Primary Device ID | 15420045512191 |
NIH Device Record Key | c6c8ae82-f032-4589-acfc-9d3edf180c11 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CERVICAL SEAL ASSY DEVICE |
Version Model Number | OLK-100 |
Catalog Number | OLK-100 |
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 | 15420045512191 [Primary] |
GS1 | 25420045512198 [Package] Package: BOX [5 Units] In Commercial Distribution |
GS1 | 35420045512195 [Package] Contains: 25420045512198 Package: BOX [5 Units] In Commercial Distribution |
GS1 | 45420045512192 [Package] Contains: 35420045512195 Package: BOX [5 Units] In Commercial Distribution |
QHZ | Seal, cervical, mechanical, unpowered |
Steralize Prior To Use | true |
Device Is Sterile | true |
[15420045512191]
Ethylene Oxide
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-09-19 |
Device Publish Date | 2019-09-11 |
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 |