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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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Omm Imports Inc.
GZ100
In Commercial Distribution

  • 00850001456456 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/ir device for the treatment of wrinkles.
Omm Imports Inc.
J700B-B
In Commercial Distribution

  • 00850001456128 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/IR led device for the treatment of wrinkles.
Omm Imports Inc.
J700B-S
In Commercial Distribution

  • 00850001456111 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red/IR device for the treatment of wrinkles.
Omm Imports Inc.
PX100
In Commercial Distribution

  • 00850001456036 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red and infrared phototherapy device for the treatment of wrinkles.
Omm Imports Inc.
P900B
In Commercial Distribution

  • 00850001456012 ()


  • Blue/red/infrared phototherapy lamp
Over the counter red and infrared phototherapy device for the treatment of wrinkles.
Omm Imports Inc.
P850B
In Commercial Distribution

  • 00850001456005 ()


  • Blue/red/infrared phototherapy lamp
ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container
NEURODX DEVELOPMENT LLC
TP-1
In Commercial Distribution

  • 00865435000335 ()
  • 10865435000318 ()
TP-1

  • Heater/cooler system tester kit
Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
NEURODX DEVELOPMENT LLC
DAQ-1
In Commercial Distribution

  • 00865435000328 ()
DAQ-1

  • Heater/cooler system tester kit
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution

  • 00865435000311 ()
SCIII SW

  • Heater/cooler system tester kit
Red LED light for the treatment of wrinkles
PULSADERM LLC
RB2010
In Commercial Distribution

  • 00864918000374 ()


  • Blue/red/infrared phototherapy lamp
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