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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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VISITAG SURPOINT External Processing Unit - 10846835017885

External Processing Unit
Biosense Webster Inc
D160801
In Commercial Distribution

  • 10846835017885 ()
D160801

  • Cardiac mapping system computer

TactiSys™ - 07640157990316

Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer

TactiSys™ - 07640157990194

Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer

ThinPrep Imaging System - 15420045504035

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504035 ()
CMP-01284

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500990

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500990 ()
CMP-00815

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500983

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500983 ()
71278-001

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500976

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500976 ()
71964-001

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045500945

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045500945 ()
71074-001

  • Laboratory instrument/analyser application software IVD

Thinprep Imaging System - 15420045513716

Computer to operate the ThinPrep® Integrated Imager.
Hologic, Inc.
Thinprep Imaging System Computer
In Commercial Distribution

  • 15420045513716 ()
CMP-01764

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045512511

Computer to operate the ThinPrep® Imaging System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512511 ()
CMP-01667

  • Laboratory instrument/analyser application software IVD
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