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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BRACKETS POS 18 CEN U/R
LEONE SPA
F2081A21
In Commercial Distribution

  • 08033707038177 ()
F2081A21

  • Orthodontic bracket, metal
DB BRACKETS SING 18 ANT U
LEONE SPA
F2080-911
In Commercial Distribution

  • 08033707037897 ()
F2080-911

  • Orthodontic bracket, metal
DB BRACKETS SING 18 ANT U
LEONE SPA
F2080-11
In Commercial Distribution

  • 08033707037842 ()
F2080-11

  • 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
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
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
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
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
CALIBRA BICUSPID BANDS UPPER KIT U
LEONE SPA
E5100-92
In Commercial Distribution

  • 08033707024897 ()
E5100-92

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

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

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

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

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

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

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

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

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

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

  • Orthodontic bracket, metal
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
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
.022 Kit U/L 5x5 Roth
ORTHO ORGANIZERS, INC.
702-397Q
In Commercial Distribution

  • 00190707044725 ()


  • Orthodontic bracket, metal
.022 Kit U/L 5x5 MC
ORTHO ORGANIZERS, INC.
4499-902Q
Not in Commercial Distribution

  • 00190707042561 ()


  • Orthodontic bracket, metal
.022 Kit U/L 5x5 Roth
ORTHO ORGANIZERS, INC.
4499-512Q
Not in Commercial Distribution

  • 00190707042349 ()


  • Orthodontic bracket, metal
.022 Kit U/L 5x5 MC
ORTHO ORGANIZERS, INC.
4499-502Q
Not in Commercial Distribution

  • 00190707042332 ()


  • Orthodontic bracket, metal
.022 Kit U/L 5x5 Roth
ORTHO ORGANIZERS, INC.
4499-122Q
Not in Commercial Distribution

  • 00190707041557 ()


  • Orthodontic bracket, metal
.018 Kit U/L 5x5 Roth
ORTHO ORGANIZERS, INC.
4499-118Q
Not in Commercial Distribution

  • 00190707041540 ()


  • Orthodontic bracket, metal
Absolute® Clear Retainers U/L
ORTHO ORGANIZERS, INC.
140-RT
In Commercial Distribution

  • 00190707101077 ()


  • Orthodontic progressive aligner
H4 U 5X5 HKS 3,4,5 CA
World Class Technology Corporation
900.2060
In Commercial Distribution

  • 00840273917076 ()
900.2060

  • Orthodontic bracket, metal
P21 PRO 5X5 U HKS 345
World Class Technology Corporation
956.2160
In Commercial Distribution

  • 00840273922490 ()
956.2160

  • Orthodontic bracket, metal
Reveal® Retainer U/L Arch
ORTHO ORGANIZERS, INC.
135-9863
In Commercial Distribution

  • 00190707089764 ()


  • Orthodontic progressive aligner
.022 Kit U/L 5x5 Roth
ORTHO ORGANIZERS, INC.
705-397Q
In Commercial Distribution

  • 00190707085445 ()


  • Orthodontic bracket, metal
P21 7X7 U/L HKS 345
World Class Technology Corporation
946.2155
In Commercial Distribution

  • 00840273900825 ()
946.2155

  • Orthodontic bracket, metal
P21 6X6 U HKS 345/-27
World Class Technology Corporation
946.2083
In Commercial Distribution

  • 00840273900788 ()
946.2083

  • Orthodontic bracket, metal
P21 7X7 U HKS 345/-27
World Class Technology Corporation
946.2080
In Commercial Distribution

  • 00840273900771 ()
946.2080

  • Orthodontic bracket, metal
P21 3X3 U/L HKS 3
World Class Technology Corporation
946.2053
In Commercial Distribution

  • 00840273900764 ()
946.2053

  • Orthodontic bracket, metal
P21 5X5 U/L HKS 345
World Class Technology Corporation
946.2032
In Commercial Distribution

  • 00840273900740 ()
946.2032

  • Orthodontic bracket, metal
MTO HARNESS REPLACEMT PS3500EP C/U
Smith & Nephew, Inc.
7204890
Not in Commercial Distribution

  • 03596010250650 ()
7204890

  • Arthroscopic shaver system, electrically-powered
OHDII FHD QL AIR04 E/U
MAQUET SAS
ARD568803968
Not in Commercial Distribution

  • 03700712418281 ()


  • Surgical video camera
BIO-ACTIVE RC U FORM A 18X25
Gc Orthodontics America Inc.
74-A0U0-1825
In Commercial Distribution

  • E53574A0U018250 ()
  • E53574A0U018251 ()
74-A0U0-1825

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

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

  • Orthodontic archwire
Protectall, Child, .25mm U, HT, Smiley
Palmero Healthcare LLC
27UHSMILEY
In Commercial Distribution

  • 00840415105545 ()
27UHSMILEY

  • Radiation shielding apron
Protectall, Child, .25mm U, HT, Black
Palmero Healthcare LLC
27UHBLACK
In Commercial Distribution

  • 00840415105538 ()
27UHBLACK

  • Radiation shielding apron
Protectall, Child, .25mm U, HT, Lavender
Palmero Healthcare LLC
27UHLAVENDER
In Commercial Distribution

  • 00840415105521 ()
27UHLAVENDER

  • Radiation shielding apron
Protectall, Child, .25mm U, HT, Royal
Palmero Healthcare LLC
27UHROYALBLUE
In Commercial Distribution

  • 00840415105514 ()
27UHROYALBLUE

  • Radiation shielding apron
Protectall, Child, .25mm U, HT, Grey
Palmero Healthcare LLC
27UHGREY
In Commercial Distribution

  • 00840415105507 ()
27UHGREY

  • Radiation shielding apron
Protectall, Child, .25mm U, HT, Blue
Palmero Healthcare LLC
27UHBLUE
In Commercial Distribution

  • 00840415105491 ()
27UHBLUE

  • Radiation shielding apron
Protectall, Child, .25mm U, HT, Beige
Palmero Healthcare LLC
27UHBEIGE
In Commercial Distribution

  • 00840415105484 ()
27UHBEIGE

  • Radiation shielding apron
Protectall, Adult, .25mm U, HT, Royal
Palmero Healthcare LLC
24UHROYALBLUE
In Commercial Distribution

  • 00840415105477 ()
24UHROYALBLUE

  • Radiation shielding apron
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