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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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LENS CONNECTED TOWER APPLICATION - 00885556778777

LENS CONNECTED TOWER APPLICATION
Smith & Nephew, Inc.
72205347
In Commercial Distribution

  • 00885556778777 ()
72205347

  • Operating room audiovisual data/device management system application software

INTEllIO LINK WEREWOLF - 00885556741641

INTELLIO LINK WEREWOLF
Smith & Nephew, Inc.
72205191
In Commercial Distribution

  • 00885556741641 ()
72205191

  • Operating room audiovisual data/device management system application software

LINK DOUBLEFLOW PUMP - 00885556741634

LINK DOUBLEFLO PUMP
Smith & Nephew, Inc.
72205190
In Commercial Distribution

  • 00885556741634 ()
72205190

  • Operating room audiovisual data/device management system application software

INTELLIO LINK Dyonics Power II - 00885556741627

INTELLIO LINK DYONICS POWER II
Smith & Nephew, Inc.
72205189
In Commercial Distribution

  • 00885556741627 ()
72205189

  • Operating room audiovisual data/device management system application software

INTELLIO Tablet - 00885556866108

INTELLIO TABLET COUNTRY KIT EN US
Smith & Nephew, Inc.
72205719
In Commercial Distribution

  • 00885556866108 ()
72205719

  • Operating room audiovisual data/device management system application software

INTELLIO Tablet - 00885556813683

INTELLIO TABLET
Smith & Nephew, Inc.
72205455
In Commercial Distribution

  • 00885556813683 ()
72205455

  • Operating room audiovisual data/device management system application software

DIGITAL DIAGNOSTICS SYSTEM - 15420045517585

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517585 ()
ASY-17964

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045517097

Computer to operate the Genius™ Review Station.
Hologic, Inc.
ASSEMBLY, REVIEW STATION COMPUTER
In Commercial Distribution

  • 15420045517097 ()
ASY-14304

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045515062

Computer to operate the ThinPrep® Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045515062 ()
CMP-01836

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045514201

Medical grade Genius™ Review Station monitor for use with the Genius™ Digital Diagnostics System.
Hologic, Inc.
DISPLAY, 27IN, 8MP
In Commercial Distribution

  • 15420045514201 ()
CMP-01669

  • Laboratory instrument/analyser application software IVD
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