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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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BETA-TITAN Form B 108 L
Gc Orthodontics America Inc.
73-B0L0-0018
In Commercial Distribution

  • E53573B0L000180 ()
  • E53573B0L000181 ()
73-B0L0-0018

  • Orthodontic archwire
BETA-TITAN Form A 018U
Gc Orthodontics America Inc.
73-A0U0-0018
In Commercial Distribution

  • E53573A0U000180 ()
  • E53573A0U000181 ()
73-A0U0-0018

  • Orthodontic archwire
BETA-Titan Form A 016L
Gc Orthodontics America Inc.
73-A0L0-0016
In Commercial Distribution

  • E53573A0L000160 ()
  • E53573A0L000161 ()
73-A0L0-0016

  • Orthodontic archwire
Bio Edge L 17x25 Form C Heavy 300 gms
Gc Orthodontics America Inc.
72-C3L0-1725
In Commercial Distribution

  • E53572C3L017250 ()
  • E53572C3L017251 ()
72-C3L0-1725

  • Orthodontic archwire
BIO-ACTIVE FORM D 19X25 LIGHT
Gc Orthodontics America Inc.
70-D100-1925
In Commercial Distribution

  • E53570D10019250 ()
  • E53570D10019251 ()
70-D100-1925

  • Orthodontic archwire
BIO-ACTIVE FORM D 18X18 LIGHT
Gc Orthodontics America Inc.
70-D100-1818
In Commercial Distribution

  • E53570D10018180 ()
  • E53570D10018181 ()
70-D100-1818

  • Orthodontic archwire
BIO-ACTIVE FORM D 16X16 LIGHT
Gc Orthodontics America Inc.
70-D100-1622
In Commercial Distribution

  • E53570D10016220 ()
  • E53570D10016221 ()
70-D100-1622

  • Orthodontic archwire
BIO-ACTIVE FORM D 14X25 LIGHT
Gc Orthodontics America Inc.
70-D100-1425
In Commercial Distribution

  • E53570D10014250 ()
  • E53570D10014251 ()
70-D100-1425

  • Orthodontic archwire
BIO-ACTIVE FORM D 014 LIGHT
Gc Orthodontics America Inc.
70-D100-0014
In Commercial Distribution

  • E53570D10000140 ()
  • E53570D10000141 ()
70-D100-0014

  • Orthodontic archwire
LIP BUMPER SZ 5 W/HK
Gc Orthodontics America Inc.
63-4105-0000
In Commercial Distribution

  • E53563410500001 ()
63-4105-0000

  • Orthodontic archwire
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