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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 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
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
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
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
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
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
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
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, 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, 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 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
MOTIVE THERAPY PAD (RIGHT), CONDUCTIVE GEL, 3 MONTH BUNDLE
Motive Health, Inc.
OT04-1003
In Commercial Distribution

  • 00850022650406 ()

  • Length: 8.58 Inch
OT04-1003

  • Electrode conductive medium
MOTIVE THERAPY PAD (LEFT), CONDUCTIVE GEL, 3 MONTH BUNDLE
Motive Health, Inc.
OT04-1002
In Commercial Distribution

  • 00850022650390 ()

  • Length: 8.58 Inch
OT04-1002

  • Electrode conductive medium
MOTIVE CONDUCTIVE GEL (3)
Motive Health, Inc.
OT03-1001
In Commercial Distribution

  • 00850022650383 ()

  • Length: 3.2 Inch
OT03-1001

  • Electrode conductive medium
MOTIVE KNEE THERAPY PADS, 1 MONTH SUPPLY, RIGHT & LEFT
Motive Health, Inc.
OT02-1004
In Commercial Distribution

  • 00850022650376 ()

  • Length: 8.58 Inch
OT02-1004

  • Electrode conductive medium
MOTIVE THERAPY PAD (LEFT), 1 MONTH BUNDLE
Motive Health, Inc.
OT02-1002
In Commercial Distribution

  • 00850022650352 ()

  • Length: 8.58 Inch
OT02-1002

  • Electrode conductive medium
e-vive II NMES System with Post-Op Brace; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-308I
In Commercial Distribution

  • 00850022650017 ()

  • Length: 16 Inch
CY-1000-308I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
MOTIVE THERAPY PAD (RIGHT), 1 MONTH BUNDLE
Motive Health, Inc.
OT02-1003
In Commercial Distribution

  • 00850022650369 ()

  • Length: 8.58 Inch
OT02-1003

  • Electrode conductive medium
MOTIVE KNEE SYSTEM, RIGHT & LEFT, STANDARD
Motive Health, Inc.
OT01-1002
In Commercial Distribution

  • 00850022650345 ()

  • Length: 39.90 Inch
OT01-1002

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Motive Knee System, Right, Standard
Motive Health, Inc.
OT01-1001
In Commercial Distribution

  • 00850022650338 ()

  • Length: 39.90 Inch
OT01-1001

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Motive Knee System, Left, Standard
Motive Health, Inc.
OT01-1000
In Commercial Distribution

  • 00850022650260 ()

  • Length: 39.90 Inch
OT01-1000

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
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