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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™ Syringes (2 mL/4 g) A3.5
Gc America Inc.
003580
In Commercial Distribution

  • D0470035801 ()

  • Total Volume: 2 Milliliter
003580

  • Light-cured dental restorative composite resin
KALORE™ Syringes (2 mL/4 g) A3
Gc America Inc.
003579
In Commercial Distribution

  • D0470035791 ()

  • Total Volume: 2 Milliliter
003579

  • Light-cured dental restorative composite resin
KALORE™ Syringes (2 mL/4 g) A2
Gc America Inc.
003578
In Commercial Distribution

  • D0470035781 ()

  • Total Volume: 2 Milliliter
003578

  • Light-cured dental restorative composite resin
KALORE™ Syringes (2 mL/4 g) A1
Gc America Inc.
003577
In Commercial Distribution

  • D0470035771 ()

  • Total Volume: 2 Milliliter
003577

  • Light-cured dental restorative composite resin
KALORE™ Syringes (2 mL/4 g) OXBW
Gc America Inc.
003576
In Commercial Distribution

  • D0470035761 ()

  • Total Volume: 2 Milliliter
003576

  • Light-cured dental restorative composite resin
KALORE™ Syringes (2 mL/4 g) OBW
Gc America Inc.
003575
In Commercial Distribution

  • D0470035751 ()

  • Total Volume: 2 Milliliter
003575

  • Light-cured dental restorative composite resin
KALORE™ Syringes (2 mL/4 g) AO4
Gc America Inc.
003574
In Commercial Distribution

  • D0470035741 ()

  • Total Volume: 2 Milliliter
003574

  • Light-cured dental restorative composite resin
KALORE™ Syringes (2 mL/4 g) AO3
Gc America Inc.
003573
In Commercial Distribution

  • D0470035731 ()

  • Total Volume: 2 Milliliter
003573

  • Light-cured dental restorative composite resin
KALORE™ Syringes (2 mL/4 g)AO2
Gc America Inc.
003572
In Commercial Distribution

  • D0470035721 ()

  • Total Volume: 2 Milliliter
003572

  • Light-cured dental restorative composite resin
G-aenial™ Universal Flo AO1 (2 mL/3.4 g per syringe)
Gc America Inc.
008468
In Commercial Distribution

  • D0470084681 ()

  • Total Volume: 2 Milliliter
008468

  • Light-cured dental restorative composite resin
G-aenial™ Flo X CV
Gc America Inc.
008324
In Commercial Distribution

  • D0470083241 ()

  • Total Volume: 2 Milliliter
008324

  • Dental composite resin
G-aenial™ Flo X AO3
Gc America Inc.
008323
In Commercial Distribution

  • D0470083231 ()

  • Total Volume: 2 Milliliter
008323

  • Dental composite resin
G-aenial™ Flo X AO2
Gc America Inc.
008322
In Commercial Distribution

  • D0470083221 ()

  • Total Volume: 2 Milliliter
008322

  • Dental composite resin
G-aenial™ Flo X A4
Gc America Inc.
008321
In Commercial Distribution

  • D0470083211 ()

  • Total Volume: 2 Milliliter
008320

  • Dental composite resin
G-aenial™ Flo X A3.5
Gc America Inc.
008320
In Commercial Distribution

  • D0470083201 ()

  • Total Volume: 2 Milliliter
008320

  • Dental composite resin
G-aenial™ Flo X A3
Gc America Inc.
008319
In Commercial Distribution

  • D0470083191 ()

  • Total Volume: 2 Milliliter
008319

  • Dental composite resin
G-aenial™ Flo X A2
Gc America Inc.
008318
In Commercial Distribution

  • D0470083181 ()

  • Total Volume: 2 Milliliter
008318

  • Dental composite resin
G-aenial™ Flo X A1
Gc America Inc.
008317
In Commercial Distribution

  • D0470083171 ()

  • Total Volume: 2 Milliliter
008317

  • Dental composite resin
G-aenial™ Universal Flo AE, 1 syringe (2 mL/3.4 g per syringe)
Gc America Inc.
004216
In Commercial Distribution

  • D0470042161 ()

  • Total Volume: 2 Milliliter
004216

  • Light-cured dental restorative composite resin
G-aenial™ JE, 1 syringe (2 mL/3.4 g per syringe) and 15 dispensing tips.
Gc America Inc.
004215
In Commercial Distribution

  • D0470042151 ()

  • Total Volume: 2 Milliliter
004215

  • Light-cured dental restorative composite resin
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