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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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The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Tytron C-5000
Not in Commercial Distribution

  • 00860447001707 ()


  • Thermographic camera
The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Tytron C-7000
In Commercial Distribution

  • 00860447001714 ()


  • Thermographic camera
Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software
Kit containing 1 left Processor & Lght Tip that are connected together and 1 right Processor & Lght Tip that are connected together Processor comes in different colors: CH - Champagne, SI - Sliver, BL - Black, BE - Beige, BR - Brown
EARLENS CORPORATION
PLEL1LR
Not in Commercial Distribution

  • 08500130070086 ()
  • 08500130070178 ()
PLEL1LR

  • Tympanic membrane contact hearing aid ear tip transmitter
  • Tympanic membrane contact hearing aid sound processor
Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
EWU01
Not in Commercial Distribution

  • 08500130070000 ()
EWU01

  • Hearing aid/implant system programming interface unit
Removable glass contact plate with grid for DL5
DermLite LLC
DL5-CPG
In Commercial Distribution

  • 00850017651524 ()
DL5-CPG

  • Dermatoscope, optical
Wound Contact Dressing Sheer 6in x 6in (WCD66-NPS)
ARGENTUM MEDICAL, LLC
WCD66-NPS
In Commercial Distribution

  • 10857278000853 ()
  • 00857278000856 ()


  • Negative-pressure wound therapy system dressing set
Wound Contact Dressing Sheer 12in x 12in (WCD-1212-NPS)
ARGENTUM MEDICAL, LLC
WCD1212-NPS
In Commercial Distribution

  • 00857278000849 ()
  • 00840247300033 ()


  • Negative-pressure wound therapy system dressing set
Wound Contact Dressing Sheer 4in X 5in (WCD45-NPS)
ARGENTUM MEDICAL, LLC
WCD45-NPS
In Commercial Distribution

  • 10857278000815 ()
  • 00857278000818 ()


  • Negative-pressure wound therapy system dressing set
Wound Contact Dressing Sheer 2in x 2in (WCD22-NPS)
ARGENTUM MEDICAL, LLC
WCD22-NPS
In Commercial Distribution

  • 10857278000808 ()
  • 00857278000801 ()


  • Negative-pressure wound therapy system dressing set
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