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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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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

Affirm Breast Biopsy Guidance System - 15420045507180

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-03668
In Commercial Distribution

  • 15420045507180 ()
  • 25420045507187 ()
ASY-03668

  • Mammographic stereotactic biopsy system

Affirm Breast Biopsy Guidance System - 15420045507173

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-03667
In Commercial Distribution

  • 15420045507173 ()
  • 25420045507170 ()
ASY-03667

  • Mammographic stereotactic biopsy system

ATEC PEARL - 15420045506855

BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC OR ULTRASOUND GUIDANCE
Hologic, Inc.
ATEC PEARL
In Commercial Distribution

  • 15420045506855 ()
ATEC PEARL

  • Mammographic stereotactic biopsy system

ATEC EMERALD - 15420045506848

BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER MRI
Hologic, Inc.
ATEC EMERALD
In Commercial Distribution

  • 15420045506848 ()
ATEC EMERALD

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506831

Selenia Dimensions Axillary Biopsy Paddle
Hologic, Inc.
ASY-05205
In Commercial Distribution

  • 15420045506831 ()
  • 25420045506838 ()
ASY-05205

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506824

Affirm Lateral Arm Upright Biopsy Accessory Lateral Arm Stand
Hologic, Inc.
ASY-09644
In Commercial Distribution

  • 15420045506824 ()
  • 25420045506821 ()
ASY-09644

  • Mammographic stereotactic biopsy system

Affirm Lateral Arm Upright Biopsy Accessory - 15420045506817

Affirm Lateral Arm Upright Biopsy Accessory
Hologic, Inc.
ASY-03723
In Commercial Distribution

  • 15420045506817 ()
  • 25420045506814 ()
ASY-03723

  • Mammographic stereotactic biopsy system

Affirm Prone Biopsy System - 15420045506541

Affirm Prone Biopsy Complete Gantry
Hologic, Inc.
ASY-09175
In Commercial Distribution

  • 15420045506541 ()
ASY-09175

  • Mammographic stereotactic biopsy system
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