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 DELL 7910 CV Ultimate Service PC
Leica Biosystems Richmond, Inc.
23CPU7910ULT_SPARE
Not in Commercial Distribution

  • 00849832010920 ()

  • Device Size Text, specify:


  • Desktop computer
Leica Biosystems CytoVision Dell Ultrasharp U2415 Monitor
Leica Biosystems Richmond, Inc.
23MON0024
Not in Commercial Distribution

  • 00849832010623 ()

  • Device Size Text, specify:


  • Image display unit, colour
Leica Biosystems CytoVision HD with Image, Dell T7500 RAID 1, Win 7
Leica Biosystems Richmond, Inc.
23DKI7517
Not in Commercial Distribution

  • 00849832009894 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5817
Not in Commercial Distribution

  • 00849832009887 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 RAID1 Win 7 Ultimate
Leica Biosystems Richmond, Inc.
23DKI5810
Not in Commercial Distribution

  • 00849832009870 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Pro
Leica Biosystems Richmond, Inc.
23DKI5807
Not in Commercial Distribution

  • 00849832009863 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Leica Biosystems CytoVision HD Image, Dell 5810 Basic Win 7 Ultimate
Leica Biosystems Richmond, Inc.
23DKI5800
Not in Commercial Distribution

  • 00849832009856 ()

  • Device Size Text, specify:


  • Hard-disc-station computer drive
Speech Generating Device - Dell Venue Android - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278116 ()


  • Voice synthesizer/digitizer
Speech Generating Device - Dell Venue Windows - 10"
Lingraphicare America, Inc.
TouchTalk
In Commercial Distribution

  • 00850042278109 ()


  • Voice synthesizer/digitizer
Remote Network Station with Dell OptiPlex 7490 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7490
In Commercial Distribution

  • 00851725007290 ()
RNS-6803-7490

  • Centralized patient monitor
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