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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 Type Device Class Implantable

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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

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

tetraCXP SW - 15099590547240

tetraCXP System
Beckman Coulter, Inc.
629638
In Commercial Distribution

  • 15099590547240 ()
629638

  • Laboratory instrument/analyser application software IVD

reticONE - 15099590572686

reticONE System
Beckman Coulter, Inc.
6915048
In Commercial Distribution

  • 15099590572686 ()
6915048

  • Laboratory instrument/analyser application software IVD

Navios EX - 15099590683269

NAVIOS EX OFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
OFFLINE ACQ 5 USERS SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683269 ()
B91239

  • Laboratory instrument/analyser application software IVD

Navios EX - 15099590683252

NAVIOS EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683252 ()
B91238

  • Laboratory instrument/analyser application software IVD

Navios EX - 15099590683245

NAVIOS EX ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
BECKMAN COULTER IRELAND INC.
ACQUISITION NEW USER SOFTWARE V2.0 WIN 7
In Commercial Distribution

  • 15099590683245 ()
B91237

  • Laboratory instrument/analyser application software IVD

EDM LITE KIT - 00809708114572

No Description
Epocal Inc
SD-0004-00-00
Not in Commercial Distribution

  • 00809708114572 ()


  • Laboratory instrument/analyser application software IVD

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
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