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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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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® - 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

LEONE SPA - 08033707024897

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

  • 08033707024897 ()
E5100-92

  • Orthodontic metal band

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 - 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 - 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

CHATTANOOGA - 00190446750604

INTELECT TRANSPORT 2 U/S DOM
DJO, LLC
4782
In Commercial Distribution

  • 00190446750604 ()


  • Physical therapy ultrasound/neuromuscular stimulation system

NA - 03596010250650

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

  • 03596010250650 ()
7204890

  • Arthroscopic shaver system, electrically-powered

Pitts21 PRO - 00840273922490

P21 PRO 5X5 U HKS 345
World Class Technology Corporation
956.2160
In Commercial Distribution

  • 00840273922490 ()
956.2160

  • Orthodontic bracket, metal

Reveal® Aligners - 00190707089764

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

  • 00190707089764 ()


  • Orthodontic progressive aligner

Contour - 00190707003494

Contour .018 Kit U 5x5 Roth
ORTHO ORGANIZERS, INC.
302-22C
In Commercial Distribution

  • 00190707003494 ()


  • Orthodontic bracket, ceramic

Contour - 00190707003487

Contour .018 Kit U 3x3 Roth
ORTHO ORGANIZERS, INC.
302-20C
In Commercial Distribution

  • 00190707003487 ()


  • Orthodontic bracket, ceramic

Quantum - 00190707005801

Quantum .022 Kit U/L 5x5
ORTHO ORGANIZERS, INC.
2783-0451
In Commercial Distribution

  • 00190707005801 ()


  • Orthodontic bracket, plastic, single-use

Quantum - 00190707005795

Quantum .018 Kit U/L 5x5
ORTHO ORGANIZERS, INC.
2783-0441
In Commercial Distribution

  • 00190707005795 ()


  • Orthodontic bracket, plastic, single-use

Contour - 00190707003630

Contour .022 Kit U 5x5 Roth
ORTHO ORGANIZERS, INC.
303-22C
In Commercial Distribution

  • 00190707003630 ()


  • Orthodontic bracket, ceramic

Contour - 00190707003623

Contour .022 Kit U 3x3 Roth
ORTHO ORGANIZERS, INC.
303-20C
In Commercial Distribution

  • 00190707003623 ()


  • Orthodontic bracket, ceramic

Delta Force® - 00190707057152

.022 Kit U/L 5x5 PHK
ORTHO ORGANIZERS, INC.
702-949PHQ
Not in Commercial Distribution

  • 00190707057152 ()


  • Orthodontic bracket, metal

Bravo Primo - 00190707041557

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

  • 00190707041557 ()


  • Orthodontic bracket, metal

Bravo Primo - 00190707041540

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

  • 00190707041540 ()


  • Orthodontic bracket, metal

Bravo Primo - 00190707042561

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

  • 00190707042561 ()


  • Orthodontic bracket, metal

Bravo Primo - 00190707042349

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

  • 00190707042349 ()


  • Orthodontic bracket, metal

Bravo Primo - 00190707042332

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

  • 00190707042332 ()


  • Orthodontic bracket, metal

Elite Opti-MIM - 00190707044725

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

  • 00190707044725 ()


  • Orthodontic bracket, metal

Pitts21 - 00840273900825

P21 7X7 U/L HKS 345
World Class Technology Corporation
946.2155
In Commercial Distribution

  • 00840273900825 ()
946.2155

  • Orthodontic bracket, metal

Pitts21 - 00840273900788

P21 6X6 U HKS 345/-27
World Class Technology Corporation
946.2083
In Commercial Distribution

  • 00840273900788 ()
946.2083

  • Orthodontic bracket, metal

Pitts21 - 00840273900771

P21 7X7 U HKS 345/-27
World Class Technology Corporation
946.2080
In Commercial Distribution

  • 00840273900771 ()
946.2080

  • Orthodontic bracket, metal

Pitts21 - 00840273900764

P21 3X3 U/L HKS 3
World Class Technology Corporation
946.2053
In Commercial Distribution

  • 00840273900764 ()
946.2053

  • Orthodontic bracket, metal

Pitts21 - 00840273900740

P21 5X5 U/L HKS 345
World Class Technology Corporation
946.2032
In Commercial Distribution

  • 00840273900740 ()
946.2032

  • Orthodontic bracket, metal

Elite® Mini-Twin® Brackets - 00190707085445

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

  • 00190707085445 ()


  • Orthodontic bracket, metal

AFFINITY MATTRESS U FOAM FOOT SECTION - 00840828162746

AFFINITY MATTRESS U FOAM FOOT SECTION
CURBELL MEDICAL PRODUCTS, INC.
SM-AFFINITY-UFT
Not in Commercial Distribution

  • 00840828162746 ()
14575

  • Orthopaedic bed mattress

AFFINITY MATTRESS U FOAM SEAT/BACK - 00840828162739

AFFINITY MATTRESS U FOAM SEAT/BACK
CURBELL MEDICAL PRODUCTS, INC.
SM-AFFINITY-USB
Not in Commercial Distribution

  • 00840828162739 ()
14574

  • Orthopaedic bed mattress

CARDINAL HEALTH - 10887488220598

STERILE MINOR W U BAR TRAY
Cardinal Health 200, LLC
SBA13MUCOG
In Commercial Distribution

  • 50887488220596 ()
  • 10887488220598 ()
SBA13MUCOG

  • General surgical procedure kit, medicated

N/A - D80705542211

LWS 022/U&L4 MED LP
DENTSPLY SIRONA ORTHODONTICS INC.
05-542-21
Not in Commercial Distribution

  • D80705542211 ()
  • D80705542210 ()
05-542-21

  • Orthodontic bracket, metal

N/A - D80705252211

TEW 022/U&L4 MED OW
DENTSPLY SIRONA ORTHODONTICS INC.
05-252-21
Not in Commercial Distribution

  • D80705252211 ()
  • D80705252210 ()
05-252-21

  • Orthodontic bracket, metal
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