| Primary Device ID | 15420045515390 |
| NIH Device Record Key | 4c58a7c8-2c2b-4188-9f97-0b8ab88f37b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sizer Set |
| Version Model Number | F0101 |
| Catalog Number | F0101 |
| Company DUNS | 018925968 |
| Company Name | Hologic, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 15420045515390 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
[15420045515390]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-21 |
| Device Publish Date | 2022-07-13 |
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| 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 |