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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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Espion - 00855730007238

E3 System, 110 Volt power supply, Envoy Mini-OLED on a table stand, No computer 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: D315-1-1-NNNNN-NN-N-T-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007238 ()


  • Electroretinograph

Espion - 00855730007221

Profile Gold System; with Xenon ColorDome 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-CDXS-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007221 ()


  • Electroretinograph

Espion - 00855730007214

Profile System; with Xenon ColorDome on an Operating Room Arm; No Power supply, 110V Cart 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-3-CDXR-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007214 ()


  • Electroretinograph

Espion - 00855730007207

E3 Console, 32-bit amplifier, amplifier stand, portable computer with Espion Software and Accessory Kit 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: D315-3-1-R-1-P
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007207 ()


  • Electroretinograph

Espion - 00855730007191

E3 Console 32-Bit Amplifier Amplifier Stand All-in-One Touch Screen Computer with Espion Software and International Accessory Kit 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: D315-3-2-R-4-D
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007191 ()


  • Electroretinograph

Espion - 00855730007184

E3 System; with Mini OLED and Portable computer 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: D315-6-2-P
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007184 ()


  • Electroretinograph

Espion - 00855730007177

E3 System; with Mini OLED, No computer 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: D315-6-1-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007177 ()


  • Electroretinograph

Espion - 00855730007153

E3 System; with Xenon ColorDome and 27" Monitor 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: D315-1-1-CDXSL-27-N-N-D
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007153 ()


  • Electroretinograph

Espion - 00855730007146

Profile System; with 27" Monitor and Mini OLED on extendable 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-B-1-27F-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007146 ()


  • Electroretinograph

Espion - 00855730007139

Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst (with stand) and Mini OLED with extendable 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-G-1-CDXR-1-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007139 ()


  • Electroretinograph

Espion - 00855730007122

Cart-only, no control unit, no power unit, with 27" Monitor 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-N-3-27F-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007122 ()


  • Electroretinograph

Espion - 00855730007115

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-G-1-CDXR-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007115 ()


  • Electroretinograph

Espion - 00855730007108

Profile System; with 27" Monitor 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-B-1-27F-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007108 ()


  • Electroretinograph

Espion - 00855730007092

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-1-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007092 ()


  • Electroretinograph

Espion - 00855730007085

Profile System; with 32" Monitor 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-1-32F-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007085 ()


  • Electroretinograph

Espion - 00855730007078

Cart-only, no control unit, with 23" Monitor 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-N-1-32F-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007078 ()


  • Electroretinograph

Espion - 00855730007061

Profile System; with Non-Xenon ColorDome 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-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007061 ()


  • Electroretinograph

Espion - 00855730007054

Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst and Mini OLED with table stand & extendable 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-G-1-23R-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007054 ()


  • Electroretinograph

Espion - 00855730007047

Profile System; with 23" Monitor on an Operating Room Arm and Mini OLED with table stand & extendable 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-B-1-23R-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007047 ()


  • Electroretinograph

Espion - 00855730007030

Profile System; with 23" Monitor and ColorBurst and Mini OLED with table stand & extendable 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-G-1-23F-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007030 ()


  • Electroretinograph

Espion - 00855730007023

Profile System; with 23" Monitor and Mini OLED with table stand & extendable 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-B-1-23F-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007023 ()


  • Electroretinograph

Espion - 00855730007016

Profile System; with 32" Monitor and ColorBurst and Mini OLED with table stand & extendable 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-G-1-32F-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007016 ()


  • Electroretinograph

Espion - 00855730007009

Profile System; with 32" Monitor and Mini OLED with table stand & extendable 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-B-1-32F-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00855730007009 ()


  • Electroretinograph

ColorBurst Handheld Stimulator - 00855730007399

The ColorBurst is a flash stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D213
In Commercial Distribution

  • 00855730007399 ()


  • Electroretinograph

LCD Benchtop Assembly w/ Monitor & Fixation Camera - 00855730007382

The LCD Monitor is a pattern stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D359
In Commercial Distribution

  • 00855730007382 ()


  • Electroretinograph

ColorFlash Handheld Stimulator - 00855730007375

The ColorFlash is a flash stimulator component that can only be used as part of the D310 & D315.
DIAGNOSYS LLC
D382
In Commercial Distribution

  • 00855730007375 ()


  • Electroretinograph

EER Stimulator and Amplifier - 00855730007368

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

Envoy Mini-OLED - 00855730007351

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

ColorDome Desktop Ganzfeld Stimulator - 00855730007344

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

Espion - 00855730007313

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

Espion - 00855730007306

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

Espion - 00855730007290

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

Espion - 00855730007283

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

Espion - 00855730007276

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

Espion - 00855730007269

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

Espion - 00855730007252

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

Motive Knee System - 00850022650468

MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD
Motive Health, Inc.
OT01-2002
In Commercial Distribution

  • 00850022650468 ()

  • Length: 39.90 Inch
OT01-2002

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Motive Knee System - 00850022650451

Motive Knee System, Right, Standard
Motive Health, Inc.
OT01-2001
In Commercial Distribution

  • 00850022650451 ()

  • Length: 39.90 Inch
OT01-2001

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Motive Knee System - 00850022650444

Motive Knee System, Left, Standard
Motive Health, Inc.
OT01-2000
In Commercial Distribution

  • 00850022650444 ()

  • Length: 39.90 Inch
OT01-2000

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

Motive Knee System - 00850022650413

MOTIVE THERAPY PAD (RIGHT & LEFT), CONDUCTIVE GEL, 3 MONTH BUNDLE
Motive Health, Inc.
OT04-1004
In Commercial Distribution

  • 00850022650413 ()

  • Length: 8.58 Inch
OT04-1004

  • Electrode conductive medium
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