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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BETA-TITAN FORM B 18X25 U (SO)
Gc Orthodontics America Inc.
73-B0U0-1825
In Commercial Distribution

  • E53573B0U018250 ()
  • E53573B0U018251 ()
73-B0U0-1825

  • Orthodontic archwire
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
BIO-ACTIVE RC U FORM B 18X25
Gc Orthodontics America Inc.
74-B0U0-1825
In Commercial Distribution

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

  • Orthodontic archwire
INITIALLOY FORM C 018 U HEAVY
Gc Orthodontics America Inc.
71-C3U0-0018
In Commercial Distribution

  • D78871C3U000180 ()
  • D78871C3U000181 ()
71-C3U0-0018

  • Orthodontic archwire
INITIALLOY FORM C 014 U HEAVY
Gc Orthodontics America Inc.
71-C3U0-0014
In Commercial Distribution

  • D78871C3U000140 ()
  • D78871C3U000141 ()
71-C3U0-0014

  • Orthodontic archwire
NI-TEK DIMPLE ARCHWIRE U/.018 PK10
DARBY DENTAL SUPPLY, LLC
0800018
In Commercial Distribution

  • 00889813056639 ()
  • 00889813056646 ()
0800018

  • Orthodontic archwire
NI-TEK DIMPLE ACHWIRE U/.016 PK10
DARBY DENTAL SUPPLY, LLC
0800016
In Commercial Distribution

  • 00889813056615 ()
  • 00889813056622 ()
0800016

  • Orthodontic archwire
NI-TEK DIMPLE ARCHWIRE U/.014 PK10
DARBY DENTAL SUPPLY, LLC
0800014
In Commercial Distribution

  • 00889813056592 ()
  • 00889813056608 ()
0800014

  • Orthodontic archwire
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