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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 ROTH 018/U/L7-7, 3HK
Gc Orthodontics America Inc.
31-1AA3-X720
In Commercial Distribution

  • D788311AA3X7201 ()
  • D788311AA3X7200 ()
31-1AA3-X720

  • Orthodontic bracket, metal
EXPC 022 MBT U 5-5 3,4HK
Gc Orthodontics America Inc.
11-2C04-0020
In Commercial Distribution

  • D788112C0400200 ()
  • D788112C0400201 ()
11-2C04-0020

  • Orthodontic bracket, ceramic
EXMRC Roth 022 U/L5-5 3HK
Gc Orthodontics America Inc.
19-1CC3-0010
In Commercial Distribution

  • D788191CC300100 ()
  • D788191CC300101 ()
19-1CC3-0010

  • Orthodontic bracket, metal
INITIALLOY FORM C 018 U HEAVY
Gc Orthodontics America Inc.
79-ACU4-2020
In Commercial Distribution

  • D78879ACU420200 ()
  • D78879ACU420201 ()
79-ACU4-2020

  • Orthodontic archwire
SS RC FORM A 18X25 U
Gc Orthodontics America Inc.
79-A2U0-1825
In Commercial Distribution

  • D78879A2U018250 ()
  • D78879A2U018251 ()
79-A2U0-1825

  • Orthodontic archwire
SS RC FORM A 16X16 U
Gc Orthodontics America Inc.
79-A2U0-1616
In Commercial Distribution

  • D78879A2U016160 ()
  • D78879A2U016161 ()
79-A2U0-1616

  • Orthodontic archwire
Reveal™ Retainer U/L Arch
HENRY SCHEIN, INC.
1359863
In Commercial Distribution

  • 10304040114329 ()
  • 00304040114322 ()
1359863

  • Orthodontic progressive aligner
SG-5 U/C SAFE-T-GUARD 5'' AIR
COMPASS HEALTH BRANDS CORP.
SG5_FG
In Commercial Distribution

  • 00815067043415 ()


  • Limb/torso/head restraint, reusable
SG-8 U/C SAFE-T-GUARD 8'' AIR
COMPASS HEALTH BRANDS CORP.
SG8_FG
In Commercial Distribution

  • 00815067043408 ()


  • Limb/torso/head restraint, reusable
MyKnee U SLIM FemPinPositioner-MRI-GMK-R-#7 ST
Medacta International SA
28.2727S
In Commercial Distribution

  • 07630345774057 ()


  • Orthopaedic prosthesis implantation positioning instrument, single-use
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