Primary Device ID | 25420045504537 |
NIH Device Record Key | 48a75ec9-2ef1-4bf2-8a5a-3807e46502dc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Myosure Reach Tissue Removal Device |
Version Model Number | 10-401FC |
Catalog Number | 10-401FC |
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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 15420045504530 [Primary] |
GS1 | 25420045504537 [Package] Contains: 15420045504530 Package: CARTON [1 Units] In Commercial Distribution |
GS1 | 35420045504534 [Package] Package: BOX [3 Units] In Commercial Distribution |
HIH | HYSTEROSCOPE (AND ACCESSORIES) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-03 |
Device Publish Date | 2023-07-26 |
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 |