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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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N/A - 00643169491779

SOFTWARE KIT 9733652 FUSION ENT US
MEDTRONIC NAVIGATION, INC.
9733652
In Commercial Distribution

  • 00643169491779 ()


  • ENT stereotactic surgery system

N/A - 00643169491762

SOFTWARE KIT 9733652XOM FUSION ENT US
MEDTRONIC NAVIGATION, INC.
9733652XOM
Not in Commercial Distribution

  • 00643169491762 ()


  • ENT stereotactic surgery system

OARtrac - 00851546007097

OARtrac Proprietary System Software for CDU
RADIADYNE, L.L.C.
OT-PSS
In Commercial Distribution

  • 00851546007097 ()
OT-PSS

  • MOSFET radiation therapy dosimetry system

Leica Biosystems CytoVision Tissue FISH Software - 00849832004400

Leica Biosystems CytoVision Tissue FISH Software
Leica Biosystems Richmond, Inc.
23SWRTFHXXX001
Not in Commercial Distribution

  • 00849832004400 ()

  • Device Size Text, specify:


  • Laboratory instrument/analyser application software IVD

Leica Biosystems CytoVision FISH Software Update - 00849832004394

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 - 00849832004387

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 - 00849832004370

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 - 00849832004363

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 - 00849832003793

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 - 00849832003724

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
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