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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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COE ALGINATE™ Fast set, mint, 1 x 1lb powder and 1 x scoop
Gc America Inc.
120101
In Commercial Distribution

  • D6581201012 ()
  • D6581201011 ()
120101

  • Silicone dental impression material
COE ALGINATE™ Normal set, mint, 1 x 1lb powder and 1 x scoop
Gc America Inc.
120001
In Commercial Distribution

  • D6581200012 ()
  • D6581200011 ()

  • Weight: 1 Pound
120001

  • Silicone dental impression material
EXAFLEX® Heavy (yellow) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138201
In Commercial Distribution

  • D6581382012 ()
  • D6581382011 ()
138201

  • Silicone dental impression material
EXAFLEX® Injection (pink) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138101
In Commercial Distribution

  • D6581381012 ()
  • D6581381011 ()
138101

  • Silicone dental impression material
OMNIFLEX™ Standard Set (1 x 90mL base, 1 x 45mL catalyst, 1 x 15mL adhesive)
Gc America Inc.
137301
In Commercial Distribution

  • D6581373012 ()
  • D6581373011 ()
137301

  • Polyether dental impression material
EXAMIX™ NDS Heavy (yellow) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137206
In Commercial Distribution

  • D6581372062 ()
  • D6581372061 ()
137206

  • Silicone dental impression material
EXA’lence™ Fast Set 48mL Cartridge Heavy Rigid Body (Green), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137104
In Commercial Distribution

  • D6581371042 ()
  • D6581371041 ()
137104

  • Silicone dental impression material
COE-PAK™ Regular Set (1 x 90g base & 1 x 90g catalyst)
Gc America Inc.
135001
In Commercial Distribution

  • D6581350012 ()
  • D6581350011 ()
135001

  • Clinical periodontal dressing
COE-FLEX® s Regular Body, Fast Set (1 x 90mL base, 1 x 45mL catalyst)
Gc America Inc.
131105
In Commercial Distribution

  • D6581311052 ()
  • D6581311051 ()
131105

  • Polyether dental impression material
COE-FLEX® s Injection Type (1 x 90mL base, 1 x 45mL catalyst)
Gc America Inc.
131103
In Commercial Distribution

  • D6581311032 ()
  • D6581311031 ()
131103

  • Polyether dental impression material
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