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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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KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO4
Gc America Inc.
003600
In Commercial Distribution

  • D0470036001 ()
  • D0470036000 ()

  • Total Volume: 0.16 Milliliter
003600

  • Light-cured dental restorative composite resin
KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO3
Gc America Inc.
003599
In Commercial Distribution

  • D0470035991 ()
  • D0470035990 ()

  • Total Volume: 0.16 Milliliter
003599

  • Light-cured dental restorative composite resin
KALORE™ Unitips (0.16 mL/0.3 g) Box of 10 unitips AO2
Gc America Inc.
003598
In Commercial Distribution

  • D0470035981 ()
  • D0470035980 ()

  • Total Volume: 0.16 Milliliter
003598

  • Light-cured dental restorative composite resin
GRADIA® DIRECT X Syringes -1 syringe 2.7 mL/5 g X-BW
Gc America Inc.
002796
In Commercial Distribution

  • D0470027961 ()

  • Total Volume: 2.7 Milliliter
002796

  • Light-cured dental restorative composite resin
GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30 g - )X-BW
Gc America Inc.
002794
In Commercial Distribution

  • D0470027941 ()
  • D0470027940 ()

  • Total Volume: 0.16 Milliliter
002794

  • Light-cured dental restorative composite resin
GRADIA® DIRECT X Unitips -10 tips 0.16 mL/0.30 g - X-XBW
Gc America Inc.
002793
In Commercial Distribution

  • D0470027931 ()
  • D0470027930 ()

  • Total Volume: 0.16 Milliliter
002793

  • Light-cured dental restorative composite resin
GRADIA® DIRECT X Syringes - 1 syringe 2.7 mL/5 g X-D2
Gc America Inc.
002611
In Commercial Distribution

  • D0470026111 ()

  • Total Volume: 2.7 Milliliter
002611

  • Light-cured dental restorative composite resin
GRADIA® DIRECT X Syringes - 1 syringe 2.7 mL/5 g X-AO2
Gc America Inc.
002607
In Commercial Distribution

  • D0470026071 ()

  • Total Volume: 2.7 Milliliter
002607

  • Light-cured dental restorative composite resin
GRADIA® DIRECT X Syringes - 1 syringe 2.7 mL/5 g X-WT
Gc America Inc.
002605
In Commercial Distribution

  • D0470026051 ()

  • Total Volume: 2.7 Milliliter
002605

  • Light-cured dental restorative composite resin
GRADIA® DIRECT X Syringes - 1 syringe 2.7 mL/5 g X-A3.5
Gc America Inc.
002604
In Commercial Distribution

  • D0470026041 ()

  • Total Volume: 2.7 Milliliter
002604

  • Light-cured dental restorative composite resin
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