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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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LMI U/L 7-7 UP 3HK 345HK
Gc Orthodontics America Inc.
31-2AA3-8920
In Commercial Distribution

  • D788312AA389200 ()
  • D788312AA389201 ()
31-2AA3-8920

  • Orthodontic bracket, metal
COMFORTUBE 018/U&L7 0T 0A 0O
Gc Orthodontics America Inc.
40-1770-0000
In Commercial Distribution

  • D78840177000000 ()
  • D78840177000001 ()
40-1770-0000

  • Orthodontic bracket, metal
EXP XT 022 U/L6-6 HK 345
Gc Orthodontics America Inc.
20-2BB5-3914
In Commercial Distribution

  • D788202BB539141 ()
20-2BB5-3914

  • Orthodontic bracket, metal
EXM MBT 022 U/L 6-6 3HK
Gc Orthodontics America Inc.
20-2BB3-0020
In Commercial Distribution

  • D788202BB300201 ()
20-2BB3-0020

  • Orthodontic bracket, metal
EXP ROTH 022 U 6-6 HK 3,4
Gc Orthodontics America Inc.
20-2B04-8439
In Commercial Distribution

  • D788202B0484390 ()
  • D788202B0484391 ()
20-2B04-8439

  • Orthodontic bracket, metal
EXPM MBT 022 U/L 7-7 345
Gc Orthodontics America Inc.
20-2AA5-9448
In Commercial Distribution

  • D788202AA594481 ()
20-2AA5-9448

  • Orthodontic bracket, metal
EXM MBT 022 U/l707 HK 345
Gc Orthodontics America Inc.
20-2AA5-9392
In Commercial Distribution

  • D788202AA593920 ()
  • D788202AA593921 ()
20-2AA5-9392

  • Orthodontic bracket, metal
EXM MBT 018 U/L 5-5 HK3,4
Gc Orthodontics America Inc.
20-1CC4-0020
In Commercial Distribution

  • D788201CC400201 ()
20-1CC4-0020

  • Orthodontic bracket, metal
EXMRC Roth BIDI U/L 5-5 HK3
Gc Orthodontics America Inc.
19-BID3-0010
In Commercial Distribution

  • D78819BID300101 ()
19-BID3-0010

  • Orthodontic bracket, metal
EXMRC Roth 022 OPT U/L 5-5
Gc Orthodontics America Inc.
19-2CC5-0021
In Commercial Distribution

  • D788192CC500211 ()
19-2CC5-0021

  • Orthodontic bracket, metal
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