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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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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

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

ThinPrep Imaging System - 15420045501034

Computer to operate the ThinPrep® Integrated Imager and Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
Not in Commercial Distribution

  • 15420045501034 ()
ASY-03446

  • 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 - 15420045500938

A system for imaging and analyzing ThinPrep® cervical cyctology sample slides.
Hologic, Inc.
ThinPrep Imaging System Imaging Station
In Commercial Distribution

  • 15420045500938 ()
71050-001

  • Laboratory instrument/analyser application software IVD
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