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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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The EER is an electrical stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D366
In Commercial Distribution

  • 00855730007368 ()


  • Electroretinograph
The Envoy Monitor is a pattern stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D352
In Commercial Distribution

  • 00855730007351 ()


  • Electroretinograph
The ColorDome is a flash stimulator component that can only be used as part of the D310 & D315 medical devices.
DIAGNOSYS LLC
D125
In Commercial Distribution

  • 00855730007344 ()


  • Electroretinograph
Attache 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).
DIAGNOSYS LLC
D341
In Commercial Distribution

  • 00855730007313 ()


  • Electroretinograph
E3 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).
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007306 ()


  • Electroretinograph
Profile 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).
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007290 ()


  • Electroretinograph
Profile System; with 27" Monitor and 100 Volt power supply 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-G-5-27F-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007283 ()


  • Electroretinograph
Profile System; with Xenon ColorDome and 100 Volt power supply 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-G-5-CDXR-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007276 ()


  • Electroretinograph
Profile System; with no stimulator and 110V Power Supply 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-G-1-NNNN-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007269 ()


  • Electroretinograph
Profile System; with Non-Xenon ColorDome and 220V Power Supply 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-G-2-CDNS-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007252 ()


  • Electroretinograph
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