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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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EXL 018/U&L4&5 UNIV 10T 0A HK
Gc Orthodontics America Inc.
16-174U-0010
In Commercial Distribution

  • D78816174U00101 ()
  • D78816174U00100 ()
16-174U-0010

  • Orthodontic bracket, metal
CHIC MINI MBT 022 U/L 5-5 HK 345
Gc Orthodontics America Inc.
15-2CC5-S020
In Commercial Distribution

  • D788152CC5S0201 ()
15-2CC5-S020

  • Orthodontic bracket, ceramic
CHIC MINI MBT 022 U/L 5-5 HK 3
Gc Orthodontics America Inc.
15-2CC3-0020
In Commercial Distribution

  • D788152CC300201 ()
15-2CC3-0020

  • Orthodontic bracket, ceramic
CHIC MINI Roth 022 U/L 5-5 HK 3
Gc Orthodontics America Inc.
15-2CC3-0010
In Commercial Distribution

  • D788152CC300101 ()
15-2CC3-0010

  • 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
LMIRC ROTH/MBT 018 U/L 6-6 HK 3
Gc Orthodontics America Inc.
38-1BB3-9150
In Commercial Distribution

  • D788381BB391501 ()
38-1BB3-9150

  • Orthodontic bracket, metal
LEGEND LMED ROTH 018/U/L 6-6, U3HKL3 4HK
Gc Orthodontics America Inc.
32-1CC4-X7567
In Commercial Distribution

  • D788321CC4X75671 ()
  • D788321CC4X75670 ()
321CC4-X7567

  • Orthodontic bracket, metal
LMI/RC 018 ROTHMBT U/L 6-6 UHK3 LHK34
Gc Orthodontics America Inc.
38/31-1B34-3969
In Commercial Distribution

  • D78838311B3439691 ()
38-31-1B34-3969

  • Orthodontic bracket, metal
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