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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 Mini OLED with table stand 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-CDNS-N-T
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007257 ()


  • Electroretinograph
Profile System; with Xenon ColorDome on an OR Arm 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-CDXR-2-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007240 ()


  • Electroretinograph
Profile System; with Non-Xenon ColorDome on OR Arm 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-CDNR-2-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007233 ()


  • Electroretinograph
E3 Console Only: 220V 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: D315-4-2
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007219 ()


  • Electroretinograph
Profile System; with Xenon ColorDome on an Operating Room Arm 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-CDXR-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007042 ()


  • Electroretinograph
The Profile System; with Non-Xenon ColorDome on an Operating Room Arm 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-CDNR-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007035 ()


  • Electroretinograph
Standalone 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
D175
In Commercial Distribution

  • 00850594007004 ()


  • Electroretinograph
EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
Endosound, Inc.
5016
In Commercial Distribution

  • 00850050934165 ()
5016

  • Flexible endoscopic ultrasound imaging transducer
The EndoSound Vision System (EVS) Software is the Microsoft Windows-based software run on a PC that processes the ultrasound data received from the EVSScanner module and displays the ultrasound image on the PC's monitor.
Endosound, Inc.
5011
In Commercial Distribution

  • 00850050934127 ()
5011

  • General-purpose ultrasound imaging system
The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable.
Endosound, Inc.
5030
In Commercial Distribution

  • 00850050934110 ()
5030

  • Invasive medical device leak tester, mechanical
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