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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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BIO-ACTIVE - D78874B0U018251

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 - D78871C3U000181

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

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

  • Orthodontic archwire

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

Darby Dental Supply, LLC - 00889813056646

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

  • 00889813056639 ()
  • 00889813056646 ()
0800018

  • Orthodontic archwire

Darby Dental Supply, LLC - 00889813056622

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

  • 00889813056615 ()
  • 00889813056622 ()
0800016

  • Orthodontic archwire

Darby Dental Supply, LLC - 00889813056608

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

  • 00889813056592 ()
  • 00889813056608 ()
0800014

  • Orthodontic archwire

Darby Dental Supply, LLC - 00889813055021

REBOUND A-WIRE NATURAL U/19X25 PK10
DARBY DENTAL SUPPLY, LLC
0741925
In Commercial Distribution

  • 00889813055014 ()
  • 00889813055021 ()
0741925

  • Orthodontic archwire

Darby Dental Supply, LLC - 00889813055007

REBOUND A-WIRE NATURAL U/18X25 PK10
DARBY DENTAL SUPPLY, LLC
0741825
In Commercial Distribution

  • 00889813054994 ()
  • 00889813055007 ()
0741825

  • Orthodontic archwire

Darby Dental Supply, LLC - 00889813054987

REBOUND A-WIRE NATURAL U/17X25 PK10
DARBY DENTAL SUPPLY, LLC
0741725
In Commercial Distribution

  • 00889813054970 ()
  • 00889813054987 ()
0741725

  • Orthodontic archwire

Darby Dental Supply, LLC - 00889813054963

REBOUND A-WIRE NATURAL U/16X22 PK10
DARBY DENTAL SUPPLY, LLC
0741622
In Commercial Distribution

  • 00889813054956 ()
  • 00889813054963 ()
0741622

  • Orthodontic archwire

Darby Dental Supply, LLC - 00889813054949

REBOUND A-WIRE NATURAL U/16X16 PK10
DARBY DENTAL SUPPLY, LLC
0741616
In Commercial Distribution

  • 00889813054932 ()
  • 00889813054949 ()
0741616

  • Orthodontic archwire

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

Standard Edgewise - D78829173000531

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

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

  • Orthodontic bracket, metal

Standard Edgewise - D78826274000531

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

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

  • Orthodontic bracket, metal

Standard Edgewise - D78826273000621

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

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

  • Orthodontic bracket, metal

Standard Edgewise - D78826273000591

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

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

  • Orthodontic bracket, metal

EXPERIENCE® - D788202E0300201

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

  • D788202E0300201 ()
20-2E03-0020

  • Orthodontic bracket, metal

EXPERIENCE® - D78820BID359331

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

  • D78820BID359331 ()
20-BID3-5933

  • Orthodontic bracket, metal

Experience - D788202E0300211

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

  • D788202E0300211 ()
20-2E03-0021

  • Orthodontic bracket, metal

EXPERIENCE® - D788191CC300101

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

EXPERIENCE® - D788112C0400201

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

WELLBRACE - 07798128672942

CORRECTOR DE POSTURA ELASTICO- U XL
PANTYMED S.A.
1203-306 U XL
In Commercial Distribution

  • 07798128672942 ()


  • Clavicle orthosis

WELLBRACE - 07798128672935

CORRECTOR DE POSTURA ELASTICO- U L
PANTYMED S.A.
1203-306 U L
In Commercial Distribution

  • 07798128672935 ()


  • Clavicle orthosis

WELLBRACE - 07798128672928

CORRECTOR DE POSTURA ELASTICO- U M
PANTYMED S.A.
1203-306 U M
In Commercial Distribution

  • 07798128672928 ()


  • Clavicle orthosis

WELLBRACE - 07798128672911

CORRECTOR DE POSTURA ELASTICO- U S
PANTYMED S.A.
1203-306 U S
In Commercial Distribution

  • 07798128672911 ()


  • Clavicle orthosis

WELLBRACE - 07798128671976

FAJA ESPINAL AIREADA - WELLBRA U 2XL
PANTYMED S.A.
1207-695 U 2XL
In Commercial Distribution

  • 07798128671976 ()


  • Lumbar spine orthosis

WELLBRACE - 07798128671969

FAJA ESPINAL AIREADA - WELLBRA U XL
PANTYMED S.A.
1207-695 U XL
In Commercial Distribution

  • 07798128671969 ()


  • Lumbar spine orthosis

WELLBRACE - 07798128671952

FAJA ESPINAL AIREADA - WELLBRA U L
PANTYMED S.A.
1207-695 U L
In Commercial Distribution

  • 07798128671952 ()


  • Lumbar spine orthosis

WELLBRACE - 07798128671945

FAJA ESPINAL AIREADA - WELLBRA U M
PANTYMED S.A.
1207-695 U M
In Commercial Distribution

  • 07798128671945 ()


  • Lumbar spine orthosis

WELLBRACE - 07798128671938

FAJA ESPINAL AIREADA - WELLBRA U S
PANTYMED S.A.
1207-695 U S
In Commercial Distribution

  • 07798128671938 ()


  • Lumbar spine orthosis

VENOMED - 07798128670696

MEDIA TERAPEUITICA HOMBRE 18-2 U L
PANTYMED S.A.
1501-21HN U L
In Commercial Distribution

  • 07798128670696 ()


  • Compression/pressure sock/stocking, reusable

VENOMED - 07798128670689

MEDIA TERAPEUITICA HOMBRE 18-2 U M
PANTYMED S.A.
1501-21HN U M
In Commercial Distribution

  • 07798128670689 ()


  • Compression/pressure sock/stocking, reusable

VENOMED - 07798128670672

MEDIA TERAPEUITICA HOMBRE 18-2 U XL
PANTYMED S.A.
1501-21HA U XL
In Commercial Distribution

  • 07798128670672 ()


  • Compression/pressure sock/stocking, reusable

VENOMED - 07798128670665

MEDIA TERAPEUITICA HOMBRE 18-2 U L
PANTYMED S.A.
1501-21HA U L
In Commercial Distribution

  • 07798128670665 ()


  • Compression/pressure sock/stocking, reusable

VENOMED - 07798128670658

MEDIA TERAPEUITICA HOMBRE 18-2 U M
PANTYMED S.A.
1501-21HA U M
In Commercial Distribution

  • 07798128670658 ()


  • Compression/pressure sock/stocking, reusable

WELLBRACE - 07798128670627

FAJA SACROLUMBAR NEOPRENE - PR U XL
PANTYMED S.A.
1207-F1 U XL
In Commercial Distribution

  • 07798128670627 ()


  • Lumbar spine orthosis

WELLBRACE - 07798094546049

SOPRTE DE CLAVICULA - WELLBRAC U L
PANTYMED S.A.
1202-L1 U L
In Commercial Distribution

  • 07798094546049 ()


  • Clavicle orthosis

WELLBRACE - 07798094546032

SOPRTE DE CLAVICULA - WELLBRAC U M
PANTYMED S.A.
1202-L1 U M
In Commercial Distribution

  • 07798094546032 ()


  • Clavicle orthosis

WELLBRACE - 07798094546025

SOPRTE DE CLAVICULA - WELLBRAC U S
PANTYMED S.A.
1202-L1 U S
In Commercial Distribution

  • 07798094546025 ()


  • Clavicle orthosis

WELLBRACE - 07798094545974

FAJA SACROLUMBAR NEOPRENE - PR U L
PANTYMED S.A.
1207-F1 U L
In Commercial Distribution

  • 07798094545974 ()


  • Lumbar spine orthosis

WELLBRACE - 07798094545967

FAJA SACROLUMBAR NEOPRENE - PR U M
PANTYMED S.A.
1207-F1 U M
In Commercial Distribution

  • 07798094545967 ()


  • Lumbar spine orthosis

WELLBRACE - 07798094545950

FAJA SACROLUMBAR NEOPRENE - PR U S
PANTYMED S.A.
1207-F1 U S
In Commercial Distribution

  • 07798094545950 ()


  • Lumbar spine orthosis
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