| 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 |
| 15420045510524 - 3Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045510616 - Selenia Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045510753 - Selenia Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045510777 - Selenia Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045510784 - Selenia Dimensions | 2024-09-26 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas |
| 15420045512641 - Dimensions | 2024-09-23 Contrast Enhanced Digital Mammography Imaging Kit |
| 15420045512658 - I-View | 2024-09-23 |
| 15420045512665 - I-View | 2024-09-23 |