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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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RapidPort®EZ Access Port Kit (0-10cc) for use with LAP-BAND® AP System Standard
ReShape Lifesciences Inc.
C-2304
In Commercial Distribution


  • 0-10cc
C-2304

  • Gastric band access port kit
Package contains: Fenom Pro Device - P/N 900-0001, GTIN 00860008017901 Configured for Australia/New Zealand AC Power Cord Cable, Australia/New Zealand - PN 415-0010
Caire Diagnostics Inc.
Fenom Pro, Australia/New Zealand
In Commercial Distribution

  • 00860008017949 ()
900-0012

  • Diagnostic spirometer, professional
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
JUSTI DENTURE RELINER SEMI RGD 1-OZ LIQUID&POWDER
AMERICAN TOOTH INDUSTRIES
072-14-0010
In Commercial Distribution

  • D772ATI1400100 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER V/SOFT 1-OZ LIQUID&POWDERS
AMERICAN TOOTH INDUSTRIES
072-14-0009
In Commercial Distribution

  • D772ATI1400090 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER SOFT 1-OZ LIQUID&POWDER
AMERICAN TOOTH INDUSTRIES
072-14-0008
In Commercial Distribution

  • D772ATI1400080 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER POWDEER 1LB
AMERICAN TOOTH INDUSTRIES
072-14-0007
In Commercial Distribution

  • D772ATI1400070 ()


  • Denture reliner, soft, home-use
JUSTI DENTURE RELINER 8OZ V/SFT LIQUID
AMERICAN TOOTH INDUSTRIES
072-14-0006
In Commercial Distribution

  • D772ATI1400060 ()


  • Denture reliner, soft, home-use
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