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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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OptiLux LED Illuminator - 00852350007020

LED Illuminator Used For Surgical Instrument Illumination
ISOLUX LLC
OptiLux
In Commercial Distribution

  • 00852350007020 ()


  • Endoscopic light source unit, line-powered

1300XSB - 00852350007006

300 Watt Xenon Illuminator Used For Surgical Instrument Illumination.
ISOLUX LLC
1300XSB
In Commercial Distribution

  • 00852350007006 ()
03-1300XSB

  • Endoscopic light source unit, line-powered

Laser Safety Goggles (fit-over frame) - 00851759007174

Laser Safety Sport Fit-Over Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard
AMD Lasers
EYEF
Not in Commercial Distribution

  • 00851759007174 ()
EYEF

  • Radiation shielding goggles/spectacles

Laser Safety Goggles (Sport Frame) - 00851759007167

Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard
AMD Lasers
EYE
Not in Commercial Distribution

  • 00851759007167 ()
EYE

  • Radiation shielding goggles/spectacles

400um Strippable Fiber - ST Connection - 00851759007150

400um strippable fiber for use with the Picasso soft-tissue dental lasers. The strippable fiber has a black strain relief and an ST connection for legacy Picasso units.
AMD Lasers
SF400-ST
Not in Commercial Distribution

  • 00851759007150 ()
SF400-ST

  • Dental diode laser system

400um Strippable Fiber - Plus Series - 00851759007143

400um strippable fiber for use with the Picasso Plus or Picasso Lite Plus soft-tissue dental lasers. The strippable fiber has a blue strain relief.
AMD Lasers
SF400-PLUS
Not in Commercial Distribution

  • 00851759007143 ()
SF400-PLUS

  • Dental diode laser system

400um Strippable Fiber - FC Connection - 00851759007136

400um strippable fiber for use with the Picasso or Picasso Lite soft-tissue dental lasers. The strippable fiber has an orange strain relief and an FC connector.
AMD Lasers
SF400-FC
Not in Commercial Distribution

  • 00851759007136 ()
SF400-FC

  • Dental diode laser system

Multi-Tip Handpiece - Picasso Lite (Black) - 00851759007129

Multi-tip handpiece (MTHP) for use with the Picasso Lite soft-tissue dental laser. This multi-tip handpiece has an black jacket.
AMD Lasers
STF200
Not in Commercial Distribution

  • 00851759007129 ()
STF200

  • Dental diode laser system

Multi-Tip Handpiece - Picasso (Orange) - 00851759007112

Multi-tip handpiece (MTHP) for use with the Picasso soft-tissue dental laser. This multi-tip handpiece has an orange jacket.
AMD Lasers
STF400
Not in Commercial Distribution

  • 00851759007112 ()
STF400

  • Dental diode laser system

Quadra Tip - 00851759007105

Quadra whitening tip for use with the the Picasso or Picasso Plus soft-tissue dental laser. Compatible with the multi-tip handpiece (MTHP).
AMD Lasers
QT
Not in Commercial Distribution

  • 00851759007105 ()
QT

  • Dental diode laser system

Multi-Tip Handpiece - Picasso Lite Plus (Black) - 00851759007099

Multi-tip handpiece (MTHP) for use with the Picasso Lite Plus soft-tissue dental laser. This multi-tip handpiece has a black jacket.
AMD Lasers
MTHP-PLPLUS
Not in Commercial Distribution

  • 00851759007099 ()
MTHP-PLPLUS

  • Dental diode laser system

Multi-Tip Handpiece - Picasso Plus (Orange) - 00851759007082

Multi-tip handpiece (MTHP) for use with the Picasso Plus soft-tissue dental laser. This multi-tip handpiece has an orange jacket.
AMD Lasers
MTHP-PPLUS
Not in Commercial Distribution

  • 00851759007082 ()
MTHP-PPLUS

  • Dental diode laser system

Picasso Plus Dental Diode Laser - 00851759007006

Picasso Plus soft-tissue dental diode laser with wireless foot control. The laser has maximum power output of 7W and working beam wavelength of 810nm.
AMD Lasers
P810
Not in Commercial Distribution

  • 00851759007006 ()
PPLUS

  • Dental diode laser system

Espion - 00850594007998

Profile System; with 23" Monitor on an Operating Room Arm and ColorBurst 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-1-23R-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007998 ()


  • Electroretinograph

Espion - 00850594007981

Profile System; with 23" Monitor on an Operating Room Arm 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-B-1-23R-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007981 ()


  • Electroretinograph

Espion - 00850594007974

Profile System; with 23" Monitor and ColorBurst 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-1-23F-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007974 ()


  • Electroretinograph

Espion - 00850594007967

Profile System; with 23" Monitor 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-B-1-23F-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007967 ()


  • Electroretinograph

Espion - 00850594007950

Profile System; with 32" Monitor and ColorBurst 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-1-32F-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007950 ()


  • Electroretinograph

Espion - 00850594007943

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

  • 00850594007943 ()


  • Electroretinograph

Espion - 00850594007936

Profile System; with Xenon ColorDome 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-CDXR-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007936 ()


  • Electroretinograph

Espion - 00850594007929

Profile System; with Non-Xenon ColorDome 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-CDNR-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007929 ()


  • Electroretinograph

Espion - 00850594007912

Profile System; with Xenon ColorDome 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-CDXS-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007912 ()


  • Electroretinograph

Espion - 00850594007905

Profile System; with Non-Xenon ColorDome 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-CDNS-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007905 ()


  • Electroretinograph

Espion - 00850594007899

Profile System; with 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-NNNN-2-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007899 ()


  • Electroretinograph

Espion - 00850594007882

Profile System; with Xenon ColorDome 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-G-1-CDXR-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007882 ()


  • Electroretinograph

Espion - 00850594007875

Profile System; with Non-Xenon ColorDome 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-G-1-CDNR-N-B
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007875 ()


  • Electroretinograph

Espion - 00850594007868

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

  • 00850594007868 ()


  • Electroretinograph

Espion - 00850594007851

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

  • 00850594007851 ()


  • Electroretinograph

Espion - 00850594007844

Profile System; with Xenon ColorDome on an Operating Room Arm and ColorBurst 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-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007844 ()


  • Electroretinograph

Espion - 00850594007837

Profile System; with Non-Xenon ColorDome on an Operating Room Arm and ColorBurst 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-CDNR-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007837 ()


  • Electroretinograph
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