| Primary Device ID | 15420045504950 |
| NIH Device Record Key | 7d20abc3-76f2-4710-aaad-9e1b69529be8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EVIVA_0910-20 |
| Version Model Number | EVIVA_0910-20 |
| Catalog Number | EVIVA_0910-20 |
| 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 | 15420045504950 [Primary] |
| GS1 | 25420045504957 [Package] Package: BOX [5 Units] In Commercial Distribution |
| GS1 | 35420045504954 [Package] Package: BOX [5 Units] In Commercial Distribution |
| KNW | INSTRUMENT, BIOPSY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[15420045504950]
Radiation Sterilization
[15420045504950]
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 |
| 25420045510347 - Omni Hysteroscopy Light Set | 2024-10-04 The OMNI™Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing di |
| 25420045510354 - Omni Hysteroscopy Standard Set | 2024-10-04 The OMNI™ Hysteroscope is used to provide viewing of the cervical canal and the uterine cavity for the purpose of performing d |
| 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 |