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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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GC Fuji II LC® - D6584250201

GC Fuji II LC® Dark Shades, Quantity of 24 capsules (5 each of A3.5, A4, B3 and B4 shades; 4 each of C4 shades; 0.33g powder; 0.085mL liquid per capsule).
Gc America Inc.
425020
In Commercial Distribution

  • D6584250201 ()
  • D6584250200 ()
425020

  • Glass ionomer dental cement

GC Fuji II LC® - D6584250151

GC Fuji II LC® Light Shades, Quantity of 24 capsules (5 each of A1, A2, A3 and B2 shades; 4 each of C2 shades; 0.33g powder; 0.085mL liquid per capsule).
Gc America Inc.
425015
In Commercial Distribution

  • D6584250151 ()
  • D6584250150 ()
425015

  • Glass ionomer dental cement

Calix Spinal Implant System - M697X03412191

36mm x 24mm x 16mm x 12° ALIF RASP
Xtant Medical Holdings, Inc.
X034-1219
In Commercial Distribution

  • M697X03412190 ()
  • M697X03412191 ()

  • Length: 36 Millimeter
  • Width: 24 Millimeter
  • Angle: 12 degree
  • Height: 16 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03412171

36mm x 24mm x 12mm x 12° ALIF RASP
Xtant Medical Holdings, Inc.
X034-1217
In Commercial Distribution

  • M697X03412170 ()
  • M697X03412171 ()

  • Length: 36 Millimeter
  • Width: 24 Millimeter
  • Angle: 12 degree
  • Height: 12 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03412161

36mm x 24mm x 10mm x 12° ALIF RASP
Xtant Medical Holdings, Inc.
X034-1216
In Commercial Distribution

  • M697X03412160 ()
  • M697X03412161 ()

  • Height: 10 Millimeter
  • Angle: 12 degree
  • Length: 36 Millimeter
  • Width: 24 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03412061

36mm x 24mm x 20mm x 8° ALIF RASP
Xtant Medical Holdings, Inc.
X034-1206
In Commercial Distribution

  • M697X03412060 ()
  • M697X03412061 ()

  • Length: 36 Millimeter
  • Height: 20 Millimeter
  • Width: 24 Millimeter
  • Angle: 8 degree


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03412031

36mm x 24mm x 14mm x 8° ALIF RASP
Xtant Medical Holdings, Inc.
X034-1203
In Commercial Distribution

  • M697X03412030 ()
  • M697X03412031 ()

  • Width: 24 Millimeter
  • Height: 14 Millimeter
  • Angle: 8 degree
  • Length: 36 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03412011

36mm x 24mm x 10mm x 8° ALIF RASP
Xtant Medical Holdings, Inc.
X034-1201
In Commercial Distribution

  • M697X03412010 ()
  • M697X03412011 ()

  • Width: 24 Millimeter
  • Angle: 8 degree
  • Height: 10 Millimeter
  • Length: 36 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03411911

36mm x 24mm x 20mm x 12° ALIF TRIAL
Xtant Medical Holdings, Inc.
X034-1191
In Commercial Distribution

  • M697X03411910 ()
  • M697X03411911 ()

  • Length: 36 Millimeter
  • Angle: 12 degree
  • Height: 20 Millimeter
  • Width: 24 Millimeter


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03411891

36mm x 24mm x 16mm x 12° ALIF TRIAL
Xtant Medical Holdings, Inc.
X034-1189
In Commercial Distribution

  • M697X03411890 ()
  • M697X03411891 ()

  • Width: 24 Millimeter
  • Height: 16 Millimeter
  • Angle: 12 degree
  • Length: 36 Millimeter


  • Polymeric spinal interbody fusion cage
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