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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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Sleep Profiler PSG2 Device kit - ezRIP
ADVANCED BRAIN MONITORING, INC.
SP29-1001, SP29-1008
In Commercial Distribution

  • 00851113007154 ()
  • 00851113007284 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PM3 Device Kit
ADVANCED BRAIN MONITORING, INC.
SP29-1002, SP29-1007
In Commercial Distribution

  • 00851113007154 ()
  • 00851113007277 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler Device Kit
ADVANCED BRAIN MONITORING, INC.
SP40-1001, SP29-1003
In Commercial Distribution

  • 00851113007154 ()
  • 00851113007208 ()


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

  • 00852350007020 ()


  • Endoscopic light source unit, line-powered
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 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 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 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 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 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
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