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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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Profile System; with Non-Xenon ColorDome and ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-CDNS-2-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007066 ()


  • Electroretinograph
Profile System; with ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-NNNN-2-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007059 ()


  • Electroretinograph
The Profle System with Xenon ColorDome & ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). It's product configuration D310-R-1-CDXS-2-N.
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007028 ()


  • Electroretinograph
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(SWISS)
In Commercial Distribution

  • 00850063034258 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(ITA)
In Commercial Distribution

  • 00850063034241 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) German
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(GER)
In Commercial Distribution

  • 00850063034234 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(FRE)
In Commercial Distribution

  • 00850063034227 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(SWISS)
In Commercial Distribution

  • 00850063034210 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850063034203 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(GER)
In Commercial Distribution

  • 00850063034197 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
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