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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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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
KALORE™ Unitips (0.16 mL/0.3 g) Box of 20 unitips A3.5
Gc America Inc.
003616
In Commercial Distribution

  • 04548161291319 ()
  • 14548161291316 ()

  • Total Volume: 0.16 Milliliter
003616

  • Dental composite resin
GRADIA® DIRECT X Syringes - 1 syringe 2.7 mL/5 g X-A3
Gc America Inc.
002603
In Commercial Distribution

  • 14548161282956 ()

  • Total Volume: 2.7 Milliliter
002603

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

  • 14548161322355 ()

  • Total Volume: 2.7 Milliliter
002796

  • Dental composite resin
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