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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™ - 14548161293129

KALORE™ Syringes (2 mL/4 g) A2
Gc America Inc.
003578
In Commercial Distribution

  • 14548161293129 ()

  • Total Volume: 2 Milliliter
003578

  • Dental composite resin

KALORE™ - 14548161293099

KALORE™ Syringes (2 mL/4 g) OBW
Gc America Inc.
003575
In Commercial Distribution

  • 14548161293099 ()

  • Total Volume: 2 Milliliter
003575

  • Dental composite resin

KALORE™ - 14548161293075

KALORE™ Syringes (2 mL/4 g) AO3
Gc America Inc.
003573
In Commercial Distribution

  • 14548161293075 ()

  • Total Volume: 2 Milliliter
003573

  • Dental composite resin

KALORE™ - 14548161293112

KALORE™ Syringes (2 mL/4 g) A1
Gc America Inc.
003577
In Commercial Distribution

  • 14548161293112 ()

  • Total Volume: 2 Milliliter
003577

  • Dental composite resin

KALORE™ - 14548161293105

KALORE™ Syringes (2 mL/4 g) OXBW
Gc America Inc.
003576
In Commercial Distribution

  • 14548161293105 ()

  • Total Volume: 2 Milliliter
003576

  • Dental composite resin

KALORE™ - 14548161293082

KALORE™ Syringes (2 mL/4 g) AO4
Gc America Inc.
003574
In Commercial Distribution

  • 14548161293082 ()

  • Total Volume: 2 Milliliter
003574

  • Dental composite resin

KALORE™ - 14548161293068

KALORE™ Syringes (2 mL/4 g)AO2
Gc America Inc.
003572
In Commercial Distribution

  • 14548161293068 ()

  • Total Volume: 2 Milliliter
003572

  • Dental composite resin

SIGNIA - 05714880210712

KIT SILK C&G 7IX ANZ MOC TR
Ws Audiology Usa, Inc.
KIT Silk C&G 7IX
In Commercial Distribution

  • 05714880210712 ()
21026859

  • Air-conduction hearing aid, in-the-ear

SIGNIA - 05714880210705

KIT SILK C&G 5IX ANZ BLK TR
Ws Audiology Usa, Inc.
KIT Silk C&G 5IX
In Commercial Distribution

  • 05714880210705 ()
21026860

  • Air-conduction hearing aid, in-the-ear

SIGNIA - 05714880210644

KIT SILK C&G 3IX ANZ MOC TR
Ws Audiology Usa, Inc.
KIT Silk C&G 3IX
In Commercial Distribution

  • 05714880210644 ()
21026866

  • Air-conduction hearing aid, in-the-ear
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