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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TD Navio Mini, Model: TDNL1, is a Speech Generating Device (aka AAC Device), Powered Communication System. It is a large, portable iOS-based device. The unit comes with its communication software in order meet the needs of individuals who cannot speak.
TOBII DYNAVOX LLC
TD Navio Maxi
In Commercial Distribution

  • 07340074602070 ()
750581

  • Voice synthesizer/digitizer
TD Navio Midi, Model: TDNM1, is a Speech Generating Device (aka AAC Device), Powered Communication System. It is a midsized, lightweight, portable iOS-based device. The unit comes with its communication software in order meet the needs of individuals who cannot speak.
TOBII DYNAVOX LLC
TD Navio Midi
In Commercial Distribution

  • 07340074602056 ()
750580

  • Voice synthesizer/digitizer
TD Navio Mini, Model: TDNS1, is a Speech Generating Device (aka AAC Device), Powered Communication System. It is a small, lightweight, portable iOS-based device. The unit comes with its communication software in order meet the needs of individuals who cannot speak.
TOBII DYNAVOX LLC
TD Navio Mini
In Commercial Distribution

  • 07340074602032 ()
750579

  • Voice synthesizer/digitizer
100NX DUO Upgrade Kit with VELOCITY
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
10137V
In Commercial Distribution

  • 10705037068173 ()
10137V

  • Plasma sterilizer
  • Instrument tray, reusable
100NX EXPRESS Upgrade Kit with VELOCITY
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
10134V
In Commercial Distribution

  • 10705037068166 ()
10134V

  • Plasma sterilizer
Chemical Indicator Tape
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
14202NL
In Commercial Distribution

  • 20705037067258 ()
  • 10705037067244 ()
14202NL

  • Chemical/physical sterilization process indicator
Biological Indicator
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
14324
Not in Commercial Distribution

  • 20705037016218 ()
  • 10705037016211 ()
  • 80705037016210 ()
14324

  • Biological sterilization indicator
Oskol 2 is an Augmentative and Alternative Communication system. Oskol 2 provides a communication tool for people with oral communication difficulties, especially those with severe motor disabilities who cannot use conventional mouse-based systems. People with conditions such as Amyotrophic Lateral Sclerosis (ALS) or Cerebral Palsy can access various applications installed on the computer using Oskol 2. Oskol 2 is specifically designed for use with gaze interaction. It incorporates an eye tracker that estimates the point on the screen where the user is looking. This allows the on-screen pointer to move in time with the user's gaze, replacing traditional mouse or touch interactions. Augmentative and Alternative Communication (AAC) tools allow users to communicate effectively.
IRISBOND CROWDBONDING SL.
Oskol2
In Commercial Distribution

  • G783OSKOL21 ()
  • G783OSKOL20 ()


  • Voice synthesizer/digitizer
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