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

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

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

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

  • Orthodontic bracket, metal
TW Edge 018/U&L3 MED
Gc Orthodontics America Inc.
29-1730-0053
In Commercial Distribution

  • D78829173000531 ()
  • D78829173000530 ()
29-1730-0053

  • Orthodontic bracket, metal
LEW 022/U&L4&5 MED
Gc Orthodontics America Inc.
26-2740-0053
In Commercial Distribution

  • D78826274000531 ()
  • D78826274000530 ()
26-2740-0053

  • Orthodontic bracket, metal
SW EDGE 022/U&L3 XWD
Gc Orthodontics America Inc.
26-2730-0062
In Commercial Distribution

  • D78826273000621 ()
  • D78826273000620 ()
26-2730-0062

  • Orthodontic bracket, metal
SW EDGE 022/U&L3 WD
Gc Orthodontics America Inc.
26-2730-0059
In Commercial Distribution

  • D78826273000591 ()
  • D78826273000590 ()
26-2730-0059

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

  • D78831BID331691 ()
31-BID3-3169

  • 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
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
EXM BIDI U/L 5-5 HK3
Gc Orthodontics America Inc.
20-BID3-5933
In Commercial Distribution

  • D78820BID359331 ()
20-BID3-5933

  • Orthodontic bracket, metal
EXM MBT 022 U 3-3, SP3HK
Gc Orthodontics America Inc.
20-2E03-0021
In Commercial Distribution

  • D788202E0300211 ()
20-2E03-0021

  • Orthodontic bracket, metal
EXM MBT 022 U 3-3, 3HK
Gc Orthodontics America Inc.
20-2E03-0020
In Commercial Distribution

  • D788202E0300201 ()
20-2E03-0020

  • Orthodontic bracket, metal
Rebreather, Ped, Elongated w/ U. Conn
MEDSOURCE INTERNATIONAL LLC
MS-25056-U
In Commercial Distribution

  • 00840155400054 ()
  • 00840155400047 ()
Not Applicable

  • Rebreathing oxygen face mask
SK2 25° ANGLED CASTABLE ABUTMENT [U]
SOADCO, S.L.
9030
In Commercial Distribution

  • 08435451610850 ()
9030

  • Dental implant suprastructure kit
CASTABLE FOR VEGA PERMANENT ABUTMENT [U]
SOADCO, S.L.
18 12 03
In Commercial Distribution

  • 08435451606624 ()
18 12 03

  • Dental implant suprastructure kit
EC G 12° CASTABLE ABUTMENT [U]
SOADCO, S.L.
10 12 14 GU
In Commercial Distribution

  • 08435451602381 ()
10 12 14 GU

  • Dental implant suprastructure kit
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