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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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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

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

Alinity m - 00884999051300

Alinity m EBV Application Specification File
ABBOTT MOLECULAR INC.
09N43-05B
In Commercial Distribution

09N43-05B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999051096

Alinity m STI Application Specification File
ABBOTT MOLECULAR INC.
09N17-03B
In Commercial Distribution

09N17-03B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999051065

Alinity m CMV Application Specification File
ABBOTT MOLECULAR INC.
09N46-05B
In Commercial Distribution

09N46-05B

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050945

Alinity m BKV Application Specification File
ABBOTT MOLECULAR INC.
09N85-05A
In Commercial Distribution

  • 00884999050945 ()
09N85-05A

  • Laboratory instrument/analyser application software IVD

Alinity m - 00884999050860

Alinity m HCV Application Specification File
ABBOTT MOLECULAR INC.
08N50-03B
In Commercial Distribution

  • 00884999050860 ()
08N50-03B

  • Laboratory instrument/analyser application software IVD
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