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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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No Description
Diagnostic Group LLC
GSI Pello
In Commercial Distribution

  • 00810046700075 ()


  • Tone audiometer
No Description
Diagnostic Group LLC
GSI 18
In Commercial Distribution

  • 00810046700006 ()


  • Tone audiometer
Blue Sky Plan Software
BLUE SKY BIO LLC
5.0
In Commercial Distribution

  • 00810060226346 ()
BSP

  • Dental treatment application software
Affirm Breast Biopsy Guidance System
Hologic, Inc.
STLC-00004-CN
In Commercial Distribution

  • 15420045518087 ()
STLC-00004-CN

  • Mammographic stereotactic biopsy system
Reusable Driver
Hologic, Inc.
BREVDRV-02
In Commercial Distribution

  • 15420045515161 ()
BREVDRV-02

  • Mammographic stereotactic biopsy system
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
No Description
Hologic, Inc.
AFFIRM™ SPECIMEN IMAGING
In Commercial Distribution

  • 15420045512931 ()


  • Mammographic stereotactic biopsy system
No Description
Hologic, Inc.
PBX-SYS-AFFIRM-2D
In Commercial Distribution

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

  • Mammographic stereotactic biopsy system
PRODUCT, HANDPIECE, CALIBRATE, 13CM, EVIVA
Hologic, Inc.
EVIVA_CALIBRATE_13CM
In Commercial Distribution

  • 15420045509962 ()
  • 25420045509969 ()
EVIVA_CALIBRATE_13CM

  • Mammographic stereotactic biopsy system
PRODUCT, BUSHING, GE, EVIVA
Hologic, Inc.
EVIVA_BUSHING_GE
In Commercial Distribution

  • 15420045509948 ()
  • 25420045509945 ()
EVIVA_BUSHING_GE

  • Mammographic stereotactic biopsy system
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