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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 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
Hologic, Inc.
ASY-03723
In Commercial Distribution

  • 15420045506817 ()
  • 25420045506814 ()
ASY-03723

  • Mammographic stereotactic biopsy system
Affirm Prone Biopsy Complete Gantry
Hologic, Inc.
ASY-09175
In Commercial Distribution

  • 15420045506541 ()
ASY-09175

  • Mammographic stereotactic biopsy system
AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION
Hologic, Inc.
ASY-08832
In Commercial Distribution

  • 15420045506534 ()
ASY-08832

  • Mammographic stereotactic biopsy system
HV GENERATOR
Hologic, Inc.
ASY-06886
In Commercial Distribution

  • 15420045506527 ()
ASY-06886

  • Mammographic stereotactic biopsy system
AFFIRM PRONE BIOPSY SYSTEM, 3D
Hologic, Inc.
PBX-SYS-AFFIRM-3D
In Commercial Distribution

  • 15420045506510 ()
PBX-SYS-AFFIRM-3D

  • Mammographic stereotactic biopsy system
AFFIRM PRONE BIOPSY SYSTEM, 2D
Hologic, Inc.
PBX-SYS-AFFIRM-2D
In Commercial Distribution

  • 15420045506503 ()
PBX-SYS-AFFIRM-2D

  • Mammographic stereotactic biopsy system
PADDLE, BIOPSY, LATERAL, 15 CM
Hologic, Inc.
ASY-08178
In Commercial Distribution

  • 15420045506497 ()
  • 25420045506494 ()
ASY-08178

  • Mammographic stereotactic biopsy system
PADDLE, BIOPSY, STANDARD, 6 CM X 7 CM
Hologic, Inc.
ASY-08176
In Commercial Distribution

  • 15420045506480 ()
  • 25420045506487 ()
ASY-08176

  • Mammographic stereotactic biopsy system
PADDLE, BIOPSY, STANDARD, 5 CM X 5 CM
Hologic, Inc.
ASY-08175
In Commercial Distribution

  • 15420045506473 ()
  • 25420045506470 ()
ASY-08175

  • Mammographic stereotactic biopsy system
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