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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Heat Pad, 3 Heat Settings, King Size 12" X 24", No Auto Shutoff
KAZ USA, INC.
HP118-EX
In Commercial Distribution

  • 00328785000078 ()
  • 10328785000075 ()


  • External electric-heating core temperature regulation system pad
Electric heating Pad MaxHeat by Softheat, 12" x 15", 3 heat settings, 60 minute auto shut-off.
KAZ USA, INC.
HP215V1
In Commercial Distribution

  • 20328785000041 ()
  • 00328785000047 ()


  • External electric-heating core temperature regulation system pad
Eyelid heat therapy system applicator 10 pk
Sight Sciences, Inc.
FG 05620
Not in Commercial Distribution

  • 10858027006256 ()
  • 00858027006259 ()
5-101

  • Eyelid heat therapy system applicator
The CRYOTECAR equipment is designed for therapies including Tecartherapy, Radiofrequency, Cryotecartherapy, Cryofrequency, and Fractional techniques. These non-invasive treatments use capacitive and resistive applicators to promote tissue heating, aiding in the temporary improvement of sagging skin, cellulite, and localized fat. Cryotecartherapy and Cryofrequency feature cooled tips for a more comfortable temperature increase. The device supports monopolar and bipolar modes, with capacitive tips for superficial heating and resistive tips for deeper tissue treatment. Fractional Cryofrequency and Radiofrequency create microscopic thermal lesions, enhancing skin tightening in facial and body aesthetics.
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Cryotecar
In Commercial Distribution

  • 07898966442933 ()


  • Freestanding electric massager
Hooke is a microcontrolled, non-ablative, high frequency radiofrequency equipment (27.12MHz), which can be used in the areas of facial and body aesthetics. The equipment has four applicators: three radiofrequency applicators, FACIAL (small bipolar applicator), BIPOLAR (body bipolar applicator) and MONOPOLAR (body monopolar applicator) and a COOLING applicator (air-cooled) for thermal comfort and preservation of the epidermis.
Ibramed Industria Brasileira de Equipamentos Medicos Eir
Hooke
In Commercial Distribution

  • 07898966442964 ()


  • Freestanding electric massager
Bed Warmer Deluxe
Battle Creek Equipment Co.
F00358
In Commercial Distribution

  • 040337013588 ()
  • 00040337003589 ()


  • Electric pad localized-body heating system
Standard Thermophore Sport
Battle Creek Equipment Co.
F00285
In Commercial Distribution

  • 00040337012857 ()
  • 00040337002858 ()


  • Electric pad localized-body heating system
Petite Thermophore Deluxe II
Battle Creek Equipment Co.
F00267
In Commercial Distribution

  • 00040337012673 ()
  • 00040337002674 ()


  • Electric pad localized-body heating system
Standard Thermophore Deluxe II
Battle Creek Equipment Co.
F00265
In Commercial Distribution

  • 00040337002650 ()
  • 00040337012659 ()


  • Electric pad localized-body heating system
Medium Thermophore Plus
Battle Creek Equipment Co.
F00256
In Commercial Distribution

  • 00040337012567 ()
  • 00040337002568 ()


  • Electric pad localized-body heating system
Medium Thermophore Deluxe
Battle Creek Equipment Co.
F00246
In Commercial Distribution

  • 00040337012468 ()
  • 00040337002469 ()


  • Electric pad localized-body heating system
Petite Thermophore Freedom II
Battle Creek Equipment Co.
F00237
In Commercial Distribution

  • 00040337002377 ()
  • 00040337012376 ()


  • Electric pad localized-body heating system
Standard Thermophore Freedom II
Battle Creek Equipment Co.
F00235
In Commercial Distribution

  • 00040337012352 ()
  • 00040337002353 ()


  • Electric pad localized-body heating system
Medium Thermophore Freedom
Battle Creek Equipment Co.
F00226
In Commercial Distribution

  • 00040337012260 ()
  • 00040337002261 ()


  • Electric pad localized-body heating system
Standard Thermophore Freedom
Battle Creek Equipment Co.
F00225
In Commercial Distribution

  • 00040337012253 ()
  • 00040337002254 ()


  • Electric pad localized-body heating system
Petite Max Heat Thermophore
Battle Creek Equipment Co.
F00177
In Commercial Distribution

  • 00040337011775 ()
  • 00040337001776 ()


  • Electric pad localized-body heating system
Muff
Battle Creek Equipment Co.
F00174
In Commercial Distribution

  • 00040337011744 ()
  • 00040337001745 ()


  • Electric pad localized-body heating system
Medium Max Heat Thermophore
Battle Creek Equipment Co.
F00156
In Commercial Distribution

  • 00040337011560 ()
  • 00040337001561 ()


  • Electric pad localized-body heating system
Thermophore MaxHeat Comfort Therapy Wrap for Neck & Shoulder
Battle Creek Equipment Co.
F00153
In Commercial Distribution

  • 00040337001530 ()


  • Electric pad localized-body heating system
Bed Warmer
Battle Creek Equipment Co.
F00058
In Commercial Distribution

  • 00040337000588 ()
  • 00040337010587 ()


  • Electric pad localized-body heating system
Medium Thermophore
Battle Creek Equipment Co.
F00056
In Commercial Distribution

  • 00040337000564 ()
  • 00040337010563 ()


  • Electric pad localized-body heating system
Petite Max Heat Thermophore
Battle Creek Equipment Co.
F80197
In Commercial Distribution

  • 00040337811979 ()
  • 00040337801970 ()


  • Electric pad localized-body heating system
Medium CSA Max Heat Thermophore
Battle Creek Equipment Co.
F80196
In Commercial Distribution

  • 00040337811962 ()
  • 00040337801963 ()


  • Electric pad localized-body heating system
Standard CSA Max Heat Thermophore
Battle Creek Equipment Co.
F80195
In Commercial Distribution

  • 00040337811955 ()
  • 00040337801956 ()


  • Electric pad localized-body heating system
Petite 220V Euro Thermophore
Battle Creek Equipment Co.
F80187
In Commercial Distribution

  • 00040337811870 ()
  • 00040337801871 ()


  • Electric pad localized-body heating system
Medium 220V Euro Thermophore
Battle Creek Equipment Co.
F80186
In Commercial Distribution

  • 00040337811863 ()
  • 00040337801864 ()


  • Electric pad localized-body heating system
Standard 220V Euro Thermophore
Battle Creek Equipment Co.
F80185
In Commercial Distribution

  • 00040337811856 ()
  • 00040337801857 ()


  • Electric pad localized-body heating system
Petite CSA Thermophore
Battle Creek Equipment Co.
F80097
In Commercial Distribution

  • 00040337810972 ()
  • 00040337800973 ()


  • Electric pad localized-body heating system
Medium CSA Thermophore
Battle Creek Equipment Co.
F80096
In Commercial Distribution

  • 00040337810965 ()
  • 00040337800966 ()


  • Electric pad localized-body heating system
Standard CSA Thermophore
Battle Creek Equipment Co.
F80095
In Commercial Distribution

  • 00040337810958 ()
  • 00040337800959 ()


  • Electric pad localized-body heating system
Petite 220V UK Thermophore
Battle Creek Equipment Co.
F80087
In Commercial Distribution

  • 00040337810873 ()
  • 00040337800874 ()


  • Electric pad localized-body heating system
Medium 220V UK Thermophore
Battle Creek Equipment Co.
F80086
In Commercial Distribution

  • 00040337810866 ()
  • 00040337800867 ()


  • Electric pad localized-body heating system
Standard 220V UK Thermophore
Battle Creek Equipment Co.
F80085
In Commercial Distribution

  • 00040337810859 ()
  • 00040337800850 ()


  • Electric pad localized-body heating system
177 Petite Max Heat Thermophore Warranty Use
Battle Creek Equipment Co.
F33177
In Commercial Distribution

  • 00040337311776 ()
  • 00040337331774 ()


  • Electric pad localized-body heating system
174 Muff Warranty Use
Battle Creek Equipment Co.
F33174
In Commercial Distribution

  • 00040337311745 ()
  • 00040337331743 ()


  • Electric pad localized-body heating system
156 Medium Max Heat Thermophore Warranty Use
Battle Creek Equipment Co.
F33156
In Commercial Distribution

  • 00040337311561 ()
  • 00040337331569 ()


  • Electric pad localized-body heating system
155 Standard Max Heat Thermophore Warranty Use
Battle Creek Equipment Co.
F33155
In Commercial Distribution

  • 00040337311554 ()
  • 00040337331552 ()


  • Electric pad localized-body heating system
177 Petite Thermophore Freedom II GSA
Battle Creek Equipment Co.
F22177
In Commercial Distribution

  • 00040337291771 ()
  • 00040337221778 ()


  • Electric pad localized-body heating system
156 Medium Thermophore Freedom II GSA
Battle Creek Equipment Co.
F22156
In Commercial Distribution

  • 00040337291566 ()
  • 00040337221563 ()


  • Electric pad localized-body heating system
155 Standard Thermophore Freedom II GSA
Battle Creek Equipment Co.
F22155
In Commercial Distribution

  • 00040337291559 ()
  • 00040337221556 ()


  • Electric pad localized-body heating system
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