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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 - 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

Motive Knee System - 00850022650406

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 Knee System - 00850022650390

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 Knee System - 00850022650383

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

  • 00850022650383 ()

  • Length: 3.2 Inch
OT03-1001

  • Electrode conductive medium

Motive Knee System - 00850022650376

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 Knee System - 00850022650352

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) - 00850022650017

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 Knee System - 00850022650369

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 - 00850022650345

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 - 00850022650338

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 - 00850022650260

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

e-vive II NMES System; 2XL/3XL, Left (ITALIAN) - 00850022650116

e-vive II NMES System; 2XL/3XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-318I
In Commercial Distribution

  • 00850022650116 ()

  • Length: 16 Inch
CY-1000-318I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System; L/XL, Left (ITALIAN) - 00850022650109

e-vive II NMES System; L/XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-317I
In Commercial Distribution

  • 00850022650109 ()

  • Length: 16 Inch
CY-1000-317I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System; S/M, Left (ITALIAN) - 00850022650093

e-vive II NMES System; S/M, Left (ITALIAN)
Motive Health, Inc.
CY-1000-316I
In Commercial Distribution

  • 00850022650093 ()

  • Length: 16 Inch
CY-1000-316I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System; 2XL/3XL, Right (ITALIAN) - 00850022650086

e-vive II NMES System; 2XL/3XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-315I
In Commercial Distribution

  • 00850022650086 ()

  • Length: 16 Inch
CY-1000-315I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System; L/XL, Right (ITALIAN) - 00850022650079

e-vive II NMES System; L/XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-314I
In Commercial Distribution

  • 00850022650079 ()

  • Length: 16 Inch
CY-1000-314I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System; S/M, Right (ITALIAN) - 00850022650062

e-vive II NMES System; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-313I
In Commercial Distribution

  • 00850022650062 ()

  • Length: 16 Inch
CY-1000-313I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left (ITALIAN) - 00850022650055

e-vive II NMES System with Post-Op Brace; 2XL/3XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-312I
In Commercial Distribution

  • 00850022650055 ()

  • Length: 16 Inch
CY-1000-312I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System with Post-Op Brace; L/XL, Left (ITALIAN) - 00850022650048

e-vive II NMES System with Post-Op Brace; L/XL, Left (ITALIAN)
Motive Health, Inc.
CY-1000-311I
In Commercial Distribution

  • 00850022650048 ()

  • Length: 16 Inch
CY-1000-311I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System with Post-Op Brace; S/M, Left (ITALIAN) - 00850022650031

e-vive II NMES System with Post-Op Brace; S/M, Left (ITALIAN)
Motive Health, Inc.
CY-1000-310I
In Commercial Distribution

  • 00850022650031 ()

  • Length: 16 Inch
CY-1000-310I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (ITALIAN) - 00850022650024

e-vive II NMES System with Post-Op Brace; 2XL/3XL, Right (ITALIAN)
Motive Health, Inc.
CY-1000-309I
In Commercial Distribution

  • 00850022650024 ()

  • Length: 16 Inch
CY-1000-309I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN) - 00850022650000

e-vive II NMES System with Post-Op Brace; S/M, Right (ITALIAN)
Motive Health, Inc.
CY-1000-307I
In Commercial Distribution

  • 00850022650000 ()

  • Length: 16 Inch
CY-1000-307I

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

NA - 05415067040756

Charger
Thoratec Corporation
16000
In Commercial Distribution

  • 05415067040756 ()
16000

  • Implant battery charger

NA - 05415067040749

Charger Kit, Lumbar
Thoratec Corporation
36000
In Commercial Distribution

  • 05415067040749 ()
36000

  • Implant battery charger

Sleep Profiler PSG2 - 00850015266997

Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(SWISS)
In Commercial Distribution

  • 00850015266997 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266980

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) German
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(GER)
In Commercial Distribution

  • 00850015266980 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler PSG2 - 00850015266973

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

  • 00850015266973 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler - 00850015266966

Sleep Profiler LE Device Kit Swiss
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(SWISS)
In Commercial Distribution

  • 00850015266966 ()


  • Electroencephalograph

Sleep Profiler - 00850015266959

Sleep Profiler LE Device Kit French
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(FRE)
In Commercial Distribution

  • 00850015266959 ()


  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266942

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) French
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(FRE)
In Commercial Distribution

  • 00850015266942 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

X-Series - 00850015266898

X24 LE Stat Device Kit Stratus
ADVANCED BRAIN MONITORING, INC.
XS30-1006.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266898 ()


  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266874

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(ITA)
In Commercial Distribution

  • 00850015266874 ()
  • 00851113007949 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler PSG2 - 00850015266867

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

  • 00850015266867 ()
  • 00851113007949 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler PSG2 - 00850015266850

Sleep Profiler PSG2 LE Device Kit No Belts (PM3) German with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(GER)
In Commercial Distribution

  • 00850015266850 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler - 00850015266829

Sleep Profiler LE Device Kit Polish
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(POL)
In Commercial Distribution

  • 00850015266829 ()


  • Electroencephalograph

Sleep Profiler - 00850015266812

Sleep Profiler LE Device Kit (Arm&Chin EMG) Polish
ADVANCED BRAIN MONITORING, INC.
SP29-1014.LE(POL)
In Commercial Distribution

  • 00850015266812 ()


  • Electroencephalograph

X-Series - 00850015266690

X24 LE Stat Device Kit Clinical
ADVANCED BRAIN MONITORING, INC.
XS30-1007.LE
In Commercial Distribution

  • 00850015266249 ()
  • 00850015266690 ()


  • Electroencephalograph

X-Series - 00850015266683

X24 LE Stat Device Kit
ADVANCED BRAIN MONITORING, INC.
XS30-1001.LE
In Commercial Distribution

  • 00850015266683 ()
  • 00850015266249 ()


  • Electroencephalograph

Sleep Profiler - 00850015266676

Sleep Profiler LE Device Kit Dutch
ADVANCED BRAIN MONITORING, INC.
SP40-1001.LE(DUT)
In Commercial Distribution

  • 00850015266676 ()


  • Electroencephalograph

Sleep Profiler PSG2 - 00850015266669

Sleep Profiler PSG2 LE Device Kit No Belts (PM3) Italian with cables
ADVANCED BRAIN MONITORING, INC.
SP29-1002.LE(ITA)
In Commercial Distribution

  • 00850015266669 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph

Sleep Profiler - 00850015266607

Sleep Profiler LE Device Kit (Arm&Chin EMG) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1014.LE(ITA)
In Commercial Distribution

  • 00850015266607 ()


  • Electroencephalograph
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