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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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QB1 NMES System - 00854691008247

QB1 NMES System; 2XL/3XL, Right
Motive Health, Inc.
QB-1000-215
In Commercial Distribution

  • 00854691008247 ()

  • Length: 16 Inch
QB-1000-215

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

QB1 NMES System - 00854691008230

QB1 NMES System; L/XL, Right
Motive Health, Inc.
QB-1000-214
In Commercial Distribution

  • 00854691008230 ()

  • Length: 16 Inch
QB-1000-214

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

QB1 NMES System - 00854691008223

QB1 NMES System; S/M, Right
Motive Health, Inc.
QB-1000-213
In Commercial Distribution

  • 00854691008223 ()

  • Length: 16 Inch
QB-1000-213

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

QB1 NMES System - 00854691008216

QB1 NMES System with Post-Op Brace; 2XL/3XL, Left
Motive Health, Inc.
QB-1000-212
In Commercial Distribution

  • 00854691008216 ()

  • Length: 16 Inch
QB-1000-212

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

QB1 NMES System - 00854691008209

QB1 NMES System with Post-Op Brace; L/XL, Left
Motive Health, Inc.
QB-1000-211
In Commercial Distribution

  • 00854691008209 ()

  • Length: 16 Inch
QB-1000-211

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

QB1 NMES System - 00854691008193

QB1 NMES System with Post-Op Brace; S/M, Left
Motive Health, Inc.
QB-1000-210
In Commercial Distribution

  • 00854691008193 ()

  • Length: 16 Inch
QB-1000-210

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

QB1 NMES System - 00854691008186

QB1 NMES System with Post-Op Brace; 2XL/3XL, Right
Motive Health, Inc.
QB-1000-209
In Commercial Distribution

  • 00854691008186 ()

  • Length: 16 Inch
QB-1000-209

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

QB1 NMES System - 00854691008179

QB1 NMES System with Post-Op Brace; L/XL, Right
Motive Health, Inc.
QB-1000-208
In Commercial Distribution

  • 00854691008179 ()

  • Length: 16 Inch
QB-1000-208

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

QB1 NMES System - 00854691008162

QB1 NMES System with Post-Op Brace; S/M, Right
Motive Health, Inc.
QB-1000-207
In Commercial Distribution

  • 00854691008162 ()

  • Length: 16 Inch
QB-1000-207

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive NMES System - 00854691008155

e-vive NMES System with Post-Op Brace; Extra Small, Left
Motive Health, Inc.
CY-1000-120
In Commercial Distribution

  • 00854691008155 ()

  • Length: 16 Inch
CY-1000-120

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive NMES System - 00854691008148

e-vive NMES System; with Post-Op Brace; Extra Small, Right
Motive Health, Inc.
CY-1000-119
In Commercial Distribution

  • 00854691008148 ()
CY-1000-119

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive NMES System - 00854691008131

e-vive NMES System; Extra Small, Left
Motive Health, Inc.
CY-1000-122
In Commercial Distribution

  • 00854691008131 ()

  • Length: 16 Inch
CY-1000-122

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive NMES System - 00854691008124

e-vive NMES System; Extra Small, Right
Motive Health, Inc.
CY-1000-121
In Commercial Distribution

  • 00854691008124 ()

  • Length: 16 Inch
CY-1000-121

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive NMES System - 00854691008100

e-vive Bilateral NMES System; 2X/3X
Motive Health, Inc.
CY-1000-053
In Commercial Distribution

  • 00854691008100 ()

  • Length: 16 Inch
CY-1000-053

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive NMES System - 00854691008094

e-vive Bilateral NMES System; Large/XL
Motive Health, Inc.
CY-1000-052
In Commercial Distribution

  • 00854691008094 ()

  • Length: 16 Inch
CY-1000-052

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive NMES System - 00854691008087

e-vive Bilateral NMES System; Small / Medium
Motive Health, Inc.
CY-1000-051
In Commercial Distribution

  • 00854691008087 ()

  • Length: 16 Inch
CY-1000-051

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

e-vive NMES System - 00854691008070

e-vive NMES System; Extra Small, Left, Bilateral Kit Label
Motive Health, Inc.
CY-1000-046
In Commercial Distribution

  • 00854691008070 ()

  • Length: 16 Inch
CY-1000-046

  • Physical therapy transcutaneous neuromuscular electrical stimulation system

ThermaZone - 00854682001356

ThermaZone Thermal Therapy Device with medical grade power supply
INNOVATIVE MEDICAL EQUIPMENT, LLC
003-99
In Commercial Distribution

  • 00854682001356 ()
003-99

  • Circulating-fluid localized thermal therapy system control unit

Fujifilm Surgical System - 00856853006016

No Description
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
EL-580FN
Not in Commercial Distribution

  • 00856853006016 ()


  • Rigid video laparoscope

Espion - 00855730007245

E3 System, 110 Volt power supply, ColorDome with Xenon & desktop OR stand (includes long cable), with power supply, and chin rest, Desktop computer & Espion Software 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-CDXRL-NN-N-N-D
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00855730007245 ()


  • Electroretinograph

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
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