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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 Prone Biopsy System - 15420045504721

No Description
Hologic, Inc.
System Software
In Commercial Distribution

  • 15420045504721 ()


  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE - 15420045504295

ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE
In Commercial Distribution

  • 15420045504295 ()
ATEC SAPPHIRE

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE25 - 15420045504288

220V-50HZ ALL IN ONE BREAST BIOPSY SYSTEMS FOR BIOPS UNDER STEREOTATIC, ULTRASOND OR MRI GUIDNCE
Hologic, Inc.
ATEC SAPPHIRE25
In Commercial Distribution

  • 15420045504288 ()
ATEC SAPPHIRE25

  • Mammographic stereotactic biopsy system

ATEC Sapphire 200 - 15420045504110

200 ALL IN ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC Sapphire 200
In Commercial Distribution

  • 15420045504110 ()
ATEC SAPPHIRE 200

  • Mammographic stereotactic biopsy system

ATEC SAPPHIRE 100 - 15420045504028

100 ALL-IN-ONE BREAST BIOPSY SYSTEM FOR BIOPSIES UNDER STEREOTACTIC, ULTRASOUND OR MRI GUIDANCE
Hologic, Inc.
ATEC SAPPHIRE 100
In Commercial Distribution

  • 15420045504028 ()
ATEC SAPPHIRE 100

  • Mammographic stereotactic biopsy system

DTX Studio™ Implant - 07332747158809

DTX Studio Implant 3.3 for Mac
Nobel Biocare AB
3.3
Not in Commercial Distribution

  • 07332747158809 ()
300843

  • Dental treatment application software

DTX Studio™ Implant - 07332747158793

DTX Studio Implant 3.3 for Win 64-bit
Nobel Biocare AB
3.3
Not in Commercial Distribution

  • 07332747158793 ()
300843

  • Dental treatment application software

IPS CaseDesigner™ - 07332747157673

IPS CaseDesigner 1.4 Mac
Nobel Biocare AB
1.4
In Commercial Distribution

  • 07332747157673 ()
300011

  • Dental treatment application software

IPS CaseDesigner™ - 07332747157666

IPS CaseDesigner 1.4 for Windows 64-bit
Nobel Biocare AB
1.4
In Commercial Distribution

  • 07332747157666 ()
300011

  • Dental treatment application software

VACORA® - 00801741079719

VACORA® Vacuum Assisted Biopsy System, Adapter Siemens™ Stereotactic Systems
Bard Peripheral Vascular, Inc.
VA1SI
Not in Commercial Distribution

  • 00801741079719 ()
VA1SI

  • Mammographic stereotactic biopsy system
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