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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
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
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
Contra Angle, Standard U, 20,000 RPM
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
75-12
Not in Commercial Distribution

  • H83475120 ()
  • 10381780506997 ()
75-12

  • Dental laboratory drilling system handpiece
Contra Angle, Standard U, 20,000 RPM
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
75-15
Not in Commercial Distribution

  • H834750150 ()
  • 10381780507017 ()
75-15

  • Dental laboratory drilling system handpiece
BIO-ACTIVE RC U FORM B 18X25
Gc Orthodontics America Inc.
74-B0U0-1825
In Commercial Distribution

  • D78874B0U018250 ()
  • D78874B0U018251 ()
74-B0U0-1825

  • Orthodontic archwire
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