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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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Leica Biosystems CytoVision FISH Software Update
Leica Biosystems Richmond, Inc.
23SWR002FLX001
Not in Commercial Distribution

  • 00849832004394 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision FISH Software Upgrade
Leica Biosystems Richmond, Inc.
23SWR001FLX001
Not in Commercial Distribution

  • 00849832004387 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Z-stack software license
Leica Biosystems Richmond, Inc.
23SWR000ZSX001
In Commercial Distribution

  • 00849832004370 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision MFISH Software License
Leica Biosystems Richmond, Inc.
23SWR000MFX001
Not in Commercial Distribution

  • 00849832004363 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping Software Update
Leica Biosystems Richmond, Inc.
23SWR002KLX001
Not in Commercial Distribution

  • 00849832003793 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Spot Counting Software
Leica Biosystems Richmond, Inc.
23SWRSPOTXX001
Not in Commercial Distribution

  • 00849832003724 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Leica Biosystems CytoVision Karyotyping Software Upgrade
Leica Biosystems Richmond, Inc.
23SWR001KLX001
Not in Commercial Distribution

  • 00849832003670 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD
Applied Speech Science for Dysarthrias, Software
PENTAX OF AMERICA, INC.
5153
Not in Commercial Distribution

  • 04961333229840 ()


  • Electroglottograph
Respiration, Phonation and Prosody Simulation, Software
PENTAX OF AMERICA, INC.
5152
Not in Commercial Distribution

  • 04961333229833 ()


  • Electroglottograph
Grael v2 System with PSG software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001771 ()
9028-0002-02

  • Polysomnograph
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