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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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JUSTI DENTURE RELINER KIT SEMI-RGD
AMERICAN TOOTH INDUSTRIES
072-14-0001
In Commercial Distribution

  • D772ATI1400010 ()


  • Denture reliner, soft, home-use
Isolation Transformer for EEG/EMG/EP systems
EB NEURO SPA
B9700041000
In Commercial Distribution

  • 08056446900666 ()


  • Constant-voltage transformer
Isolation Transformer for EEG/EMG/EP systems
EB NEURO SPA
B9700041001
In Commercial Distribution

  • 08056446900659 ()


  • Constant-voltage transformer
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
MAJESTIC DRUG CO. INC.
1
In Commercial Distribution

  • 00010705400968 ()
  • 50010705400963 ()
  • 30010705400969 ()
  • 40010705400966 ()
  • 20010705400962 ()


  • Denture reliner, soft, home-use
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00372494101960 ()


  • Denture reliner, soft, home-use
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755199686 ()
X-095.12.252

  • Constant-voltage transformer
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755199679 ()
X-095.12.250

  • Constant-voltage transformer
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431591
In Commercial Distribution

  • 04056869975559 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431590
In Commercial Distribution

  • 04056869975535 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431567
In Commercial Distribution

  • 04056869975528 ()


  • SPECT system application software
  • PET system application software
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