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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 Karyotyping Station w/Jai MV4 Camera
Leica Biosystems Richmond, Inc.
23CAP001KXX001
Not in Commercial Distribution

  • 00849832003373 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision K/F Station w/ Jai MV4 Camera
Leica Biosystems Richmond, Inc.
23CAP001KFX001
Not in Commercial Distribution

  • 00849832003366 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision MB8 scanning system for Karyotyping
Leica Biosystems Richmond, Inc.
23MBX008KXX001
Not in Commercial Distribution

  • 00849832003359 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision MB8 scanning system for Karyotyping &FISH
Leica Biosystems Richmond, Inc.
23MBX008KFX001
Not in Commercial Distribution

  • 00849832003342 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision GSL120 scanning system for Karyotyping
Leica Biosystems Richmond, Inc.
23GSL120KXX001
In Commercial Distribution

  • 00849832003335 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision GSL120 scanning system Karyotyping & FISH
Leica Biosystems Richmond, Inc.
23GSL120KFX001
Not in Commercial Distribution

  • 00849832003328 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision GSL10 scanning system for Karyotyping
Leica Biosystems Richmond, Inc.
23GSL10XKXX001
Not in Commercial Distribution

  • 00849832003311 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
Leica Biosystems CytoVision GSL10 scanning sys for Karyotyping &FISH
Leica Biosystems Richmond, Inc.
23GSL10XKFX001
Not in Commercial Distribution

  • 00849832003304 ()

  • Device Size Text, specify:


  • Cell morphology analyser IVD, automated/semi-automated
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SAKURA FINETEK U.S.A., INC.
9023
In Commercial Distribution

  • 00615233082404 ()
9023

  • Cell morphology analyser IVD, automated/semi-automated
Holter Analysis System
MORTARA INSTRUMENT, INC.
HSERV-6AA-XXXXA
In Commercial Distribution

  • 00812345029857 ()


  • Electrocardiographic long-term ambulatory recording analyser application software
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