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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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EXM ACO 022 U/L 5-5 HK U3, L34
Gc Orthodontics America Inc.
20-2C34-3819
In Commercial Distribution

  • D788202C3438191 ()
20-2C34-3819

  • Orthodontic bracket, metal
EXM ROTH 022 U/L 5-5 HK U3, L34
Gc Orthodontics America Inc.
20-2C34-0010
In Commercial Distribution

  • D788202C3400100 ()
  • D788202C3400101 ()
20-2C34-0010

  • Orthodontic bracket, metal
Exp ACO 022 U/L 6-6 LP HK 345
Gc Orthodontics America Inc.
20-2BB5-07LP
In Commercial Distribution

  • D788202BB507LP1 ()
20-2BB5-07LP

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

  • D788202AA579581 ()
20-2AA5-7958

  • Orthodontic bracket, metal
EXPM MINI 018/022 U/L 7-7 HK 345
Gc Orthodontics America Inc.
21-2BI5-3127
In Commercial Distribution

  • D788212BI531271 ()
21-2BI5-3127

  • 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
LMI ROTH/MBT 018 U/L 6-6 HK 3
Gc Orthodontics America Inc.
31-1BB3-9150
In Commercial Distribution

  • D788311BB391501 ()
31-1BB3-9150

  • Orthodontic bracket, metal
EXMRC ROTH 022 U/L 5-5 HK U3, L34
Gc Orthodontics America Inc.
19-2C34-0010
In Commercial Distribution

  • D788192C3400101 ()
19-2C34-0010

  • Orthodontic bracket, metal
EXMRC ROTH 022 U/L SL 6-6 HK 345
Gc Orthodontics America Inc.
19-2BB5-0010
In Commercial Distribution

  • D788192BB500101 ()
19-2BB5-0010

  • Orthodontic bracket, metal
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