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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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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
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