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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Eviva - 15420045509733

No Description
Hologic, Inc.
Eviva_STX_KIT_13cm
In Commercial Distribution

  • 15420045509733 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509726

PRODUCT, EVIVA, ADAPTER
Hologic, Inc.
EVIVA_ADAPTER
In Commercial Distribution

  • 15420045509726 ()
  • 25420045509723 ()
EVIVA_ADAPTER

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507807

A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system.
Hologic, Inc.
BREVADPTR
In Commercial Distribution

  • 15420045507807 ()
  • 25420045507804 ()
BREVADPTR

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507760

The reusable device driver is the electromechanical component of the Brevera(R) (R) Breast Biopsy system.
Hologic, Inc.
BREVDRV
In Commercial Distribution

  • 15420045507760 ()
  • 25420045507767 ()
BREVDRV

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045504738

AFFIRM SYSTEM, S/W 3D LICENSE
Hologic, Inc.
3D System Software
In Commercial Distribution

  • 15420045504738 ()
SW-04300

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045504721

No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE - 15420045504295

ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE
In Commercial Distribution

  • 15420045504295 ()
ATEC SAPPHIRE

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE25 - 15420045504288

220V-50HZ ALL IN ONE BREAST BIOPSY SYSTEMS FOR BIOPS UNDER STEREOTATIC, ULTRASOND OR MRI GUIDNCE
Hologic, Inc.
ATEC SAPPHIRE25
In Commercial Distribution

  • 15420045504288 ()
ATEC SAPPHIRE25

  • Mammographic stereotactic biopsy system

ATEC Sapphire 200 - 15420045504110

200 ALL IN ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC Sapphire 200
In Commercial Distribution

  • 15420045504110 ()
ATEC SAPPHIRE 200

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE 100 - 15420045504028

100 ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE 100
In Commercial Distribution

  • 15420045504028 ()
ATEC SAPPHIRE 100

  • Mammographic stereotactic biopsy system

AFFIRM™ CONTRAST BIOPSY - 15420045512948

Affirm® 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.
Hologic, Inc.
AFFIRM™ CONTRAST BIOPSY SOFTWARE
In Commercial Distribution

  • 15420045512948 ()
CMP-01771

  • Mammographic stereotactic biopsy system

AFFIRM™ SPECIMEN IMAGING - 15420045512931

No Description
Hologic, Inc.
AFFIRM™ SPECIMEN IMAGING
In Commercial Distribution

  • 15420045512931 ()


  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045512863

Single-use, disposable needle for acquiring biopsy specimens.
Hologic, Inc.
BREVDISP09
In Commercial Distribution

  • 15420045512863 ()
  • 15420045512870 ()
BREVDISP09

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045510845

No Description
Hologic, Inc.
PBX-SYS-AFFIRM-2D
In Commercial Distribution

  • 15420045510845 ()
PBX-SYS-AFFIRM-2D

  • Mammographic stereotactic biopsy system

Eviva - 15420045509962

PRODUCT, HANDPIECE, CALIBRATE, 13CM, EVIVA
Hologic, Inc.
EVIVA_CALIBRATE_13CM
In Commercial Distribution

  • 15420045509962 ()
  • 25420045509969 ()
EVIVA_CALIBRATE_13CM

  • Mammographic stereotactic biopsy system

Eviva - 15420045509948

PRODUCT, BUSHING, GE, EVIVA
Hologic, Inc.
EVIVA_BUSHING_GE
In Commercial Distribution

  • 15420045509948 ()
  • 25420045509945 ()
EVIVA_BUSHING_GE

  • Mammographic stereotactic biopsy system

Eviva - 15420045509931

No Description
Hologic, Inc.
EVIVA_STX_KIT_GIOTTO
In Commercial Distribution

  • 15420045509931 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509924

No Description
Hologic, Inc.
EVIVA_STX_KIT_INSPIR
In Commercial Distribution

  • 15420045509924 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509917

No Description
Hologic, Inc.
Eviva_STX_Kit_Opdima
In Commercial Distribution

  • 15420045509917 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509900

No Description
Hologic, Inc.
Eviva_STX_Kit_Affirm
In Commercial Distribution

  • 15420045509900 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509894

No Description
Hologic, Inc.
Eviva_STX_KIT_GEL-V
In Commercial Distribution

  • 15420045509894 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509887

No Description
Hologic, Inc.
Eviva_STX_KIT_GEVER
In Commercial Distribution

  • 15420045509887 ()


  • Mammographic stereotactic biopsy system

Eviva - 15420045509863

No Description
Hologic, Inc.
Eviva_STX_KIT_SLOC
In Commercial Distribution

  • 15420045509863 ()


  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507852

A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system.
Hologic, Inc.
BREVADPTRG
In Commercial Distribution

  • 15420045507852 ()
  • 25420045507859 ()
BREVADPTRG

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507838

A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system.
Hologic, Inc.
BREVADPTRM
In Commercial Distribution

  • 15420045507838 ()
  • 25420045507835 ()
BREVADPTRM

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507821

Stylet Bracket
Hologic, Inc.
BREVSTYLBRKT
In Commercial Distribution

  • 15420045507821 ()
  • 25420045507828 ()
BREVSTYLBRKT

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507777

Single-use, disposable needle for acquiring biopsy specimens.
Hologic, Inc.
BREV09
Not in Commercial Distribution

  • 15420045507777 ()
  • 35420045507771 ()
BREV09

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507753

Vacuum-assisted biopsy device used to remove breast tissue in a minimally invasive manner using stereotactic or tomosyntheses imaging.
Hologic, Inc.
BREV200
In Commercial Distribution

  • 15420045507753 ()
BREV200

  • Mammographic stereotactic biopsy system

Brevera Breast Biopsy System - 15420045507517

Vacuum-assisted biopsy device used to remove breast tissue in a minimally invasive manner using stereotactic or tomosyntheses imaging.
Hologic, Inc.
BREV100
In Commercial Distribution

  • 15420045507517 ()
  • 25420045507514 ()
BREV100

  • Mammographic stereotactic biopsy system

Affirm Breast Biopsy Guidance System - 15420045507197

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-03669
In Commercial Distribution

  • 15420045507197 ()
  • 25420045507194 ()
ASY-03669

  • Mammographic stereotactic biopsy system
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