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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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Bath System - Har Sys23 HM P200+ Des
Arjohuntleigh AB
AD32801US2011
In Commercial Distribution

  • 05055982709279 ()


  • Hydrotherapy bath/tank
Bath System - Har Sys23 HM P200+ Des
Arjohuntleigh AB
AD32801US2010
In Commercial Distribution

  • 05055982709262 ()


  • Hydrotherapy bath/tank
Bath System - Har Sys23 HM P200+ Des
Arjohuntleigh AB
AD32801US2001
In Commercial Distribution

  • 05055982709255 ()


  • Hydrotherapy bath/tank
Bath System - Har Sys23 HM P200+ Des
Arjohuntleigh AB
AD32801US2000
In Commercial Distribution

  • 05055982709248 ()


  • Hydrotherapy bath/tank
Bath System - Har Sys23 HM P200+ Des
Arjohuntleigh AB
AD32801US1011
In Commercial Distribution

  • 05055982709231 ()


  • Hydrotherapy bath/tank
Bath System - Har Sys23 HM P200+ Des
Arjohuntleigh AB
AD32801US1010
In Commercial Distribution

  • 05055982709224 ()


  • Hydrotherapy bath/tank
Bath System - Har Sys23 HM P200+ Des
Arjohuntleigh AB
AD32801US1001
In Commercial Distribution

  • 05055982709217 ()


  • Hydrotherapy bath/tank
Plus Cryo Console
SAKURA FINETEK U.S.A., INC.
5250
In Commercial Distribution

  • 00615233079459 ()
5250

  • Tissue embedding unit IVD
Embedding Console System
SAKURA FINETEK U.S.A., INC.
5110
In Commercial Distribution

  • 00615233009746 ()
5110

  • Tissue embedding unit IVD
Cryo Module (Requires connnection to product code 5108 for operation)
SAKURA FINETEK U.S.A., INC.
5109
In Commercial Distribution

  • 04946433600515 ()
5109

  • Tissue embedding unit IVD
Embedding Module
SAKURA FINETEK U.S.A., INC.
5108
In Commercial Distribution

  • 04946433600508 ()
5108

  • Tissue embedding unit IVD
Plus Cryo Console
SAKURA FINETEK U.S.A., INC.
5250
In Commercial Distribution

  • 04946433600492 ()
5250

  • Tissue embedding unit IVD
Automated Embedder
SAKURA FINETEK U.S.A., INC.
7090
In Commercial Distribution

  • 04946433600362 ()
7090

  • Tissue embedding unit IVD
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-P
Not in Commercial Distribution

  • 60896128002130 ()


  • Extravascular-circulation hyperthermia system
Cold Plate
SAKURA FINETEK U.S.A., INC.
4650
In Commercial Distribution

  • 10615233078664 ()
  • 00615233078667 ()
4650

  • Tissue embedding unit IVD
Sebacia Microparticles Box of 9 vials
Coronado Aesthetics, LLC
SEB-250-3P-US
In Commercial Distribution

  • G256SEB2503PUS1 ()
  • G256SEB2503PUS0 ()

  • Total Volume: 3 Milliliter
SEB2503PUS

  • Photothermal therapy gel
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-D
Not in Commercial Distribution

  • 20896128002132 ()


  • Extravascular-circulation hyperthermia system
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-SW
Not in Commercial Distribution

  • 80896128002134 ()


  • Extravascular-circulation hyperthermia system
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-S
Not in Commercial Distribution

  • 70896128002137 ()


  • Extravascular-circulation hyperthermia system
Sebacia Microparticles ia a medical device consisting of engineered gold microparticles suspension intended for single use topical application. Sebacia Microparticles are designed to work as an accessory to a commercially available medically approved 1064nm laser by preferentially absorbing the light and converting it to heat, creating a focal thermal effect to the follicle and sebaceous gland for the treatment of acne vulgaris.
SEBACIA, INC.
SEB-250-3P-US
In Commercial Distribution

  • 20850002391019 ()
  • 10850002391111 ()

  • Total Volume: 3 Milliliter
SEB-250-3P-US

  • Photothermal therapy gel
No Description
BELMONT INSTRUMENT CORPORATION
902-00001A-F
Not in Commercial Distribution

  • 30896128002139 ()


  • Extravascular-circulation hyperthermia system
Hilo-Bath TR 1700 TMV2, 40 MM DRAINAGE
Tr Equipment AB
05191743
In Commercial Distribution

  • 07350016061926 ()


  • Hydrotherapy bath/tank
Hilo-Bath TR 1700 TMV3, 40 MM DRAINAGE
Tr Equipment AB
05191742
In Commercial Distribution

  • 07350016061919 ()


  • Hydrotherapy bath/tank
No Description
Tr Equipment AB
05191714
In Commercial Distribution

  • 07350016061902 ()


  • Hydrotherapy bath/tank
TR1700 HI LO 110V incl. Mixer and shower
Tr Equipment AB
05191706
In Commercial Distribution

  • 07350016061858 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING+HEIGHT ADJUSTIBLE BATH (ABCV01)
Tr Equipment AB
05100002
In Commercial Distribution

  • 07350016061841 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING BATH TMV2
Tr Equipment AB
05100003
In Commercial Distribution

  • 07350016061834 ()


  • Hydrotherapy bath/tank
TR SWING BATH RECLING BATH (ABCF01)
Tr Equipment AB
05100000
In Commercial Distribution

  • 07350016061827 ()


  • Hydrotherapy bath/tank
TR1700 HI LO 230V, NO mixer
Tr Equipment AB
05191700
In Commercial Distribution

  • 07350016061810 ()


  • Hydrotherapy bath/tank
Hilo Bath TR 900CA US, With Stainless Bathtub
Tr Equipment AB
05192167-SS
In Commercial Distribution

  • 07350016061780 ()


  • Hydrotherapy bath/tank
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