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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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Kaluza C - 15099590705145

Kaluza C 10 User Network Educational License
Beckman Coulter, Inc.
10 User Network Educational License
In Commercial Distribution

  • 15099590705145 ()
C10580

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705138

Kaluza C Single User 1 Year Educational License
Beckman Coulter, Inc.
Single User 1 Year Educational License
In Commercial Distribution

  • 15099590705138 ()
C10579

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705121

Kaluza C Perpetual Education License
Beckman Coulter, Inc.
Perpetual Education License
In Commercial Distribution

  • 15099590705121 ()
C10578

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705114

Kaluza C 5 User Network
Beckman Coulter, Inc.
5 User Network
In Commercial Distribution

  • 15099590705114 ()
C10576

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705107

Kaluza C 10 User Network
Beckman Coulter, Inc.
10 User Network
In Commercial Distribution

  • 15099590705107 ()
C10577

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705091

Kaluza C Single Use 1 Year License
Beckman Coulter, Inc.
Single Use 1 Year License
In Commercial Distribution

  • 15099590705091 ()
C10575

  • Laboratory instrument/analyser application software IVD

Kaluza C - 15099590705084

Kaluza C Perpetual License
Beckman Coulter, Inc.
Perpetual License
In Commercial Distribution

  • 15099590705084 ()
C10574

  • Laboratory instrument/analyser application software IVD

DIGITAL DIAGNOSTICS SYSTEM - 15420045513914

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

  • 15420045513914 ()
ASY-14304

  • 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 - 15420045512535

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

  • 15420045512535 ()
ASY-13755

  • Laboratory instrument/analyser application software IVD
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