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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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INITIALLOY - D78871C3U000141

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

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

  • Orthodontic archwire

LEGEND - D78831BID331691

LMI BID VSLOT U/L7-7 HK3
Gc Orthodontics America Inc.
31-BID3-3169
In Commercial Distribution

  • D78831BID331691 ()
31-BID3-3169

  • Orthodontic bracket, metal

LMI - D788311AA3X7201

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

Standard Edgewise - D78829276000621

TW Edge 022/U&L6 XWD
Gc Orthodontics America Inc.
29-2760-0062
In Commercial Distribution

  • D78829276000621 ()
  • D78829276000620 ()
29-2760-0062

  • Orthodontic bracket, metal

Standard Edgewise - D78829276000591

TW Edge 022/U&L6 WD
Gc Orthodontics America Inc.
29-2760-0059
In Commercial Distribution

  • D78829276000591 ()
  • D78829276000590 ()
29-2760-0059

  • Orthodontic bracket, metal

Standard Edgewise - D78829273000591

TW Edge 022/U&L3 WD
Gc Orthodontics America Inc.
29-2730-0059
In Commercial Distribution

  • D78829273000591 ()
  • D78829273000590 ()
29-2730-0059

  • Orthodontic bracket, metal

Standard Edgewise - D78829273000531

TW Edge 022/U&L3 MED
Gc Orthodontics America Inc.
29-2730-0053
In Commercial Distribution

  • D78829273000531 ()
  • D78829273000530 ()
29-2730-0053

  • Orthodontic bracket, metal

Standard Edgewise - D78829176000621

TW Edge 018/U&L6 XWD
Gc Orthodontics America Inc.
29-1760-0062
In Commercial Distribution

  • D78829176000621 ()
  • D78829176000620 ()
29-1760-0062

  • Orthodontic bracket, metal

Standard Edgewise - D78829176000591

TW Edge 018/U&L6 WD
Gc Orthodontics America Inc.
29-1760-0059
In Commercial Distribution

  • D78829176000591 ()
  • D78829176000590 ()
29-1760-0059

  • Orthodontic bracket, metal

Standard Edgewise - D78829173000591

TW Edge 018/U&L3 WD
Gc Orthodontics America Inc.
29-1730-0059
In Commercial Distribution

  • D78829173000591 ()
  • D78829173000590 ()
29-1730-0059

  • Orthodontic bracket, metal
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