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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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EXC ROTH 022 U/L 5-5 HK U3, L34
Gc Orthodontics America Inc.
11-2C34-0010
In Commercial Distribution

  • D788112C3400101 ()
11-2C34-0010

  • Orthodontic bracket, ceramic
EXC/M ROTH 022 U/L 7-7 HK 34
Gc Orthodontics America Inc.
11-2AA4-9356
In Commercial Distribution

  • D788112AA493561 ()
11-2AA4-9356

  • Orthodontic bracket, metal
  • Orthodontic bracket, ceramic
EXC U 5-5/EXM L 5-5 022 HK 345
Gc Orthodontics America Inc.
11/20-2CC5-X224
In Commercial Distribution

  • D78811202CC5X2241 ()
11/20-2CC5-X224

  • Orthodontic bracket, ceramic
  • Orthodontic bracket, metal
EXPC/M MBT 022 U/L 7-7 HK 3,4,5
Gc Orthodontics America Inc.
11/20-2AA5-7958
In Commercial Distribution

  • D78811202AA579581 ()
11/20-2AA5-7958

  • Orthodontic bracket, ceramic
LMI GOLD MBT 022 U/L 6-6 HK 345
Gc Orthodontics America Inc.
31-2BB5-GP20
In Commercial Distribution

  • D788312BB5GP201 ()
31-2BB5-GP20

  • Orthodontic bracket, metal
LMI ROTH/MBT U/L 7-7 HK U3, L34
Gc Orthodontics America Inc.
31-2A34-8153
In Commercial Distribution

  • D788312A3481531 ()
31-2A34-8153

  • Orthodontic bracket, metal
EXM MBT/ROTH 022 U/L 5-5 HK 345
Gc Orthodontics America Inc.
20-2CC5-X9326
In Commercial Distribution

  • D788202CC5X93261 ()
20-2CC5-X9326

  • Orthodontic bracket, metal
EXM ROTH/MBT 022 U/L 5-5 HK 345
Gc Orthodontics America Inc.
20-2CC5-9326
In Commercial Distribution

  • D788202CC593261 ()
20-2CC5-9326

  • Orthodontic bracket, metal
EXP ROTH 022 U/L 5-5 D HK 34
Gc Orthodontics America Inc.
20-2CC4-D010
In Commercial Distribution

  • D788202CC4D0101 ()
20-2CC4-D010

  • Orthodontic bracket, metal
EXP XT 022 U/L 5-5 HK U3, L345
Gc Orthodontics America Inc.
20-2C35-0030
In Commercial Distribution

  • D788202C3500301 ()
20-2C35-0030

  • Orthodontic bracket, metal
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