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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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Temporary Cement Clear NE Automix Syringe 5ml. 1/bx. + 10 Mixing Tips - MARK3
CARGUS INTERNATIONAL, INC
4126
In Commercial Distribution

  • D79641261 ()
  • D79641262 ()
4126

  • Zinc oxide eugenol dental cement
Temporary Cement NE Automix Syringe 5ml. 2/bx. + 20 Mixing Tips - MARK3®
CARGUS INTERNATIONAL, INC
4125
In Commercial Distribution

  • D79641250 ()
  • D79641251 ()
  • D79641252 ()
4125

  • Zinc oxide eugenol dental cement
Isolation Gown Tie-Back Medium Knit Cuff Sky Blue 25g. 10/pk. - MARK3*
CARGUS INTERNATIONAL, INC
3260B
In Commercial Distribution

  • D7963260B2 ()
  • D7963260B1 ()
3260B

  • Professional examination gown, single-use
VPS 380 Impression Material Heavy Body Fast Set 2/pk. - MARK3®*
CARGUS INTERNATIONAL, INC
3027
In Commercial Distribution

  • D79630270 ()
  • D79630271 ()
  • D79630272 ()
3027

  • Silicone dental impression material
VPS 380 Impression Material Monophase Regular Set 2/pk. - MARK3
CARGUS INTERNATIONAL, INC
3026
In Commercial Distribution

  • D79630261 ()
  • D79630260 ()
  • D79630262 ()


  • Silicone dental impression material
VPS 380 Impression Material Heavy Body Regular Set 2/pk. - MARK3
CARGUS INTERNATIONAL, INC
3025
In Commercial Distribution

  • D79630251 ()
  • D79630250 ()
  • D79630252 ()


  • Silicone dental impression material
VPS Impression Material Monophase Fast Set 50ml. Cartridges 100/cs. - MARK3
CARGUS INTERNATIONAL, INC
3017BULK
In Commercial Distribution

  • D7963017BULK1 ()
  • D7963017BULK0 ()
  • D7963017BULK2 ()


  • Silicone dental impression material
STERILIZATION POUCHES - 7-1/2" X 12"
PURELIFE, LLC
1190106
Not in Commercial Distribution

  • D79011901063 ()
  • D79011901061 ()
  • D79011901060 ()

  • 7-1/2" X 12"
1190106

  • Sterilization packaging, single-use
5 1/4" x 10" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink
PURELIFE, LLC
1190105
In Commercial Distribution

  • D79011901053 ()
  • D79011901051 ()
  • D79011901050 ()

  • 5-1/4" X 10"
1190105

  • Sterilization packaging, single-use
3 1/2" x 9" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink
PURELIFE, LLC
1190104
In Commercial Distribution

  • D79011901043 ()
  • D79011901041 ()
  • D79011901040 ()

  • 3-1/2" X 9"
1190104

  • Sterilization packaging, single-use
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