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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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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
PADDLE, BIOPSY, AXILLA, 5 CM X 5 CM
Hologic, Inc.
ASY-08174
In Commercial Distribution

  • 15420045506466 ()
  • 25420045506463 ()
ASY-08174

  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
3-000-2247
Not in Commercial Distribution

  • 15420045506077 ()
3-000-2247

  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
8-004-0017
Not in Commercial Distribution

  • 15420045505926 ()
8-004-0017

  • Mammographic stereotactic biopsy system
Affirm Breast Biopsy Guidance System
Hologic, Inc.
STLC-00004
In Commercial Distribution

  • 15420045505858 ()
STLC-00004

  • Mammographic stereotactic biopsy system
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