Primary Device ID | 15420045512948 |
NIH Device Record Key | cdff0717-26ac-4df0-bb3b-44dc674a0761 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AFFIRM™ CONTRAST BIOPSY |
Version Model Number | AFFIRM™ CONTRAST BIOPSY SOFTWARE |
Catalog Number | CMP-01771 |
Company DUNS | 139534114 |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 15420045512948 [Primary] |
IZH | System, x-ray, mammographic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-04-19 |
Device Publish Date | 2020-11-18 |
15420045512948 - AFFIRM™ CONTRAST BIOPSY | 2024-04-19Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices. |
15420045512948 - AFFIRM™ CONTRAST BIOPSY | 2024-04-19 Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dim |
15420045511446 - Panther Fusion® | 2024-04-15 Epstein-Barr virus (EBV) Primers ASR. |
15420045511453 - Panther Fusion® | 2024-04-15 Epstein-Barr virus (EBV) Probe ASR. |
15420045511552 - Panther Fusion® | 2024-04-15 Hologic GAS Plasmid Control. |
15420045511576 - Panther Fusion® | 2024-04-15 Group A Strep (GAS) Probe ASR. |
15420045511590 - Panther Fusion® | 2024-04-15 Group A Strep (GAS) Primers ASR. |
15420045512122 - Panther Fusion® | 2024-04-15 Hologic EBV Plasmid Control. |
15420045515529 - OMNI | 2024-02-27 The Omni Hysteroscopic Scissors are sterile, single-use, hand actuated hysteroscopic scissors that are intended to be used by a |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AFFIRM 98486479 not registered Live/Pending |
First Orion Corp. 2024-04-05 |
AFFIRM 97899818 not registered Live/Pending |
Resilient Floor Covering Institute, Inc. 2023-04-20 |
AFFIRM 97872095 not registered Live/Pending |
Affirm, Inc. 2023-04-04 |
AFFIRM 97872079 not registered Live/Pending |
Affirm, Inc. 2023-04-04 |
AFFIRM 97821735 not registered Live/Pending |
Avlon Industries, Inc. 2023-03-03 |
AFFIRM 97611420 not registered Live/Pending |
Keeton, Lou 2022-09-28 |
AFFIRM 97227986 not registered Live/Pending |
Affirm National Legal Nurse ConsultantsLLC 2022-01-19 |
AFFIRM 97058970 not registered Live/Pending |
Resilient Floor Covering Institute, Inc. 2021-10-04 |
AFFIRM 90760546 not registered Live/Pending |
C-P Converters, Inc. 2021-06-08 |
AFFIRM 90623193 not registered Live/Pending |
Affirm, Inc. 2021-04-05 |
AFFIRM 90623184 not registered Live/Pending |
Affirm, Inc. 2021-04-05 |
AFFIRM 90260110 not registered Live/Pending |
Sauder Woodworking Co. 2020-10-16 |