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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 AO3
Gc America Inc.
003599
In Commercial Distribution

  • 04548161293337 ()
  • 14548161293334 ()

  • Total Volume: 0.16 Milliliter
003599

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

  • 04548161293320 ()
  • 14548161293327 ()

  • Total Volume: 0.16 Milliliter
003598

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

  • 14548161292238 ()

  • Total Volume: 2.7 Milliliter
002607

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

  • 14548161292221 ()

  • Total Volume: 2.7 Milliliter
002605

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

  • 14548161292214 ()

  • Total Volume: 2.7 Milliliter
002604

  • Dental composite resin
GRADIA® DIRECT X Syringes -1 syringe 2.7 mL/5 g X-A1
Gc America Inc.
002601
In Commercial Distribution

  • 14548161292207 ()

  • Total Volume: 2.7 Milliliter
002601

  • Dental composite resin
GRADIA® DIRECT X Unitips -20 tips 0.16 mL/0.30 g X-WT
Gc America Inc.
002594
In Commercial Distribution

  • 04548161292187 ()
  • 14548161292184 ()

  • Total Volume: 0.16 Milliliter
002594

  • Dental composite resin
GRADIA® DIRECT X Unitips -20 tips 0.16 mL/0.30 g X-A3.5
Gc America Inc.
002593
In Commercial Distribution

  • 04548161292170 ()
  • 14548161292177 ()

  • Total Volume: 0.16 Milliliter
002593

  • Dental composite resin
GRADIA® DIRECT X Unitips -20 tips 0.16 mL/0.30 g X-A3
Gc America Inc.
002592
In Commercial Distribution

  • 04548161292163 ()
  • 14548161292160 ()

  • Total Volume: 0.16 Milliliter
002592

  • Dental composite resin
GRADIA® DIRECT X Unitips -20 tips 0.16 mL/0.30 g X-A2
Gc America Inc.
002591
In Commercial Distribution

  • 04548161292156 ()
  • 14548161292153 ()

  • Total Volume: 0.16 Milliliter
002591

  • Dental composite resin
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