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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BioQuick-Brackets Roth .018" 480 Brackets 3-5 w. hook (6-6)
Forestadent Bernhard Förster GmbH
-706X0984
In Commercial Distribution

  • EFOR706X09841 ()


  • Orthodontic bracket, metal
BioQuick-Brackets Roth .018" 120 Brackets 3-5 w. hook (6-6)
Forestadent Bernhard Förster GmbH
-706X0982
In Commercial Distribution

  • EFOR706X09821 ()


  • Orthodontic bracket, metal
BioQuick-Brackets Roth .022" 1400 Brackets 3-5 w. hook (7-7)
Forestadent Bernhard Förster GmbH
-706V1000
In Commercial Distribution

  • EFOR706V10001 ()


  • Orthodontic bracket, metal
BioQuick-Brackets Roth .022" 560 Brackets 3-5 w. hook (7-7)
Forestadent Bernhard Förster GmbH
-706V0999
In Commercial Distribution

  • EFOR706V09991 ()


  • Orthodontic bracket, metal
BioQuick-Brackets Roth .022" 280 Brackets 3-5 w. hook (7-7)
Forestadent Bernhard Förster GmbH
-706V0998
In Commercial Distribution

  • EFOR706V09981 ()


  • Orthodontic bracket, metal
BioQuick-Brackets Roth .022" 28 Brackets 3-5 w. hook (7-7)
Forestadent Bernhard Förster GmbH
-706V0996
In Commercial Distribution

  • EFOR706V09961 ()


  • Orthodontic bracket, metal
Assembly, Fortex, 8.25 x 35 Cannulated Mini Reduction Screw
Xtant Medical Holdings, Inc.
X064-82535C
In Commercial Distribution

  • M697X06482535C1 ()

  • Outer Diameter: 8.25 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex Mini Reduction, 7.5 x 35 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X064-7535SD
In Commercial Distribution

  • M697X0647535SD1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 7.5 x 35 Cannulated Mini Reduction Screw
Xtant Medical Holdings, Inc.
X064-7535C
In Commercial Distribution

  • M697X0647535C1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex Mini Reduction, 6.5 x 35 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X064-6535SD
In Commercial Distribution

  • M697X0646535SD1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 6.5 x 35 Cannulated Mini Reduction Screw
Xtant Medical Holdings, Inc.
X064-6535C
In Commercial Distribution

  • M697X0646535C1 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex Mini Reduction, 5.5 x 35 Self-Drilling Screw
Xtant Medical Holdings, Inc.
X064-5535SD
In Commercial Distribution

  • M697X0645535SD1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 5.5 x 35 Cannulated Mini Reduction Screw
Xtant Medical Holdings, Inc.
X064-5535C
In Commercial Distribution

  • M697X0645535C1 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 35 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 4.75 x 35 Cannulated Mini Reduction Screw
Xtant Medical Holdings, Inc.
X064-47535C
In Commercial Distribution

  • M697X06447535C1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 8.25 x 35 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0026-DL
In Commercial Distribution

  • M697X0640026DL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 8.25 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 7.5 x 35 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0020-DL
In Commercial Distribution

  • M697X0640020DL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 6.5 x 35 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0014-DL
In Commercial Distribution

  • M697X0640014DL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 5.5 x 35 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0008-DL
In Commercial Distribution

  • M697X0640008DL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
Assembly, Fortex, 4.75 x 35 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0002-DL
In Commercial Distribution

  • M697X0640002DL1 ()

  • Length: 35 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Spinal bone screw, non-bioabsorbable
dentaform® Snap, tooth 46,size 35/Roth 22
DENTAURUM GmbH & Co.KG
880-335-22
In Commercial Distribution

  • J011880335220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 32/Roth 22
DENTAURUM GmbH & Co.KG
862-132-22
In Commercial Distribution

  • J011862132220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 32/Roth 18
DENTAURUM GmbH & Co.KG
862-132-18
In Commercial Distribution

  • J011862132180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 31/Roth 22
DENTAURUM GmbH & Co.KG
862-131-22
In Commercial Distribution

  • J011862131220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 31/Roth 18
DENTAURUM GmbH & Co.KG
862-131-18
In Commercial Distribution

  • J011862131180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 30/Roth 22
DENTAURUM GmbH & Co.KG
862-130-22
In Commercial Distribution

  • J011862130220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 30/Roth 18
DENTAURUM GmbH & Co.KG
862-130-18
In Commercial Distribution

  • J011862130180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 29/Roth 22
DENTAURUM GmbH & Co.KG
862-129-22
In Commercial Distribution

  • J011862129220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 29/Roth 18
DENTAURUM GmbH & Co.KG
862-129-18
In Commercial Distribution

  • J011862129180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 28/Roth 22
DENTAURUM GmbH & Co.KG
862-128-22
In Commercial Distribution

  • J011862128220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 28/Roth 18
DENTAURUM GmbH & Co.KG
862-128-18
In Commercial Distribution

  • J011862128180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 27/Roth 22
DENTAURUM GmbH & Co.KG
862-127-22
In Commercial Distribution

  • J011862127220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 27/Roth 18
DENTAURUM GmbH & Co.KG
862-127-18
In Commercial Distribution

  • J011862127180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 25/Roth 22
DENTAURUM GmbH & Co.KG
862-125-22
In Commercial Distribution

  • J011862125220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 25/Roth 18
DENTAURUM GmbH & Co.KG
862-125-18
In Commercial Distribution

  • J011862125180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 24/Roth 22
DENTAURUM GmbH & Co.KG
862-124-22
In Commercial Distribution

  • J011862124220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 24/Roth 18
DENTAURUM GmbH & Co.KG
862-124-18
In Commercial Distribution

  • J011862124180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 23/Roth 22
DENTAURUM GmbH & Co.KG
862-123-22
In Commercial Distribution

  • J011862123220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 23/Roth 18
DENTAURUM GmbH & Co.KG
862-123-18
In Commercial Distribution

  • J011862123180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 22/Roth 22
DENTAURUM GmbH & Co.KG
862-122-22
In Commercial Distribution

  • J011862122220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 22/Roth 18
DENTAURUM GmbH & Co.KG
862-122-18
In Commercial Distribution

  • J011862122180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 21/Roth 22
DENTAURUM GmbH & Co.KG
862-121-22
In Commercial Distribution

  • J011862121220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 21/Roth 18
DENTAURUM GmbH & Co.KG
862-121-18
In Commercial Distribution

  • J011862121180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 20/Roth 22
DENTAURUM GmbH & Co.KG
862-120-22
In Commercial Distribution

  • J011862120220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 20/Roth 18
DENTAURUM GmbH & Co.KG
862-120-18
In Commercial Distribution

  • J011862120180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 19/Roth 22
DENTAURUM GmbH & Co.KG
862-119-22
In Commercial Distribution

  • J011862119220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 19/Roth 18
DENTAURUM GmbH & Co.KG
862-119-18
In Commercial Distribution

  • J011862119180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 18/Roth 22
DENTAURUM GmbH & Co.KG
862-118-22
In Commercial Distribution

  • J011862118220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 18/Roth 18
DENTAURUM GmbH & Co.KG
862-118-18
In Commercial Distribution

  • J011862118180 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 17/Roth 22
DENTAURUM GmbH & Co.KG
862-117-22
In Commercial Distribution

  • J011862117220 ()


  • Orthodontic metal band
Standard Band, Tooth 45/35, Size 17/Roth 18
DENTAURUM GmbH & Co.KG
862-117-18
In Commercial Distribution

  • J011862117180 ()


  • Orthodontic metal band
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