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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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IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 19mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-24PC-STR
In Commercial Distribution

  • M697X08038281924PCSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 24°, 19mm height


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 24°, 17mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-24PC-STR
In Commercial Distribution

  • M697X08038281724PCSTR1 ()

  • 28mm depth X 24°, 17mm height
  • Width: 38 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 19mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-332619-24PC-STR
In Commercial Distribution

  • M697X08033261924PCSTR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 24°, 19mm height


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 33 X 26 X 24°, 17mm, PC (STERILE)
Xtant Medical Holdings, Inc.
X080-332617-24PC-STR
In Commercial Distribution

  • M697X08033261724PCSTR1 ()

  • Width: 33 Millimeter
  • 26mm depth X 24°, 17mm height


  • Metal-polymer composite spinal interbody fusion cage
24" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched)
APPLIED MEDICAL TECHNOLOGY, INC.
ES1-2421
In Commercial Distribution

  • 00842071148362 ()
  • 00842071148355 ()

  • Length: 24 Inch
ES1-2421, S1-2421

  • Suprapubic drainage catheter
6mm Tibial BP, Stemmed, Hole, No Peg, Half Wrap, R, 0, 0° Slope
Shalby Advanced Technologies, Inc.
2598-0-6020
In Commercial Distribution

  • 00840286833288 ()
2598-0-6020

  • Uncoated knee tibia prosthesis, metallic
4mm Tibial BP, Stemmed, Hole, No Peg, Half Wrap, R, 0, 0° Slope
Shalby Advanced Technologies, Inc.
2598-0-4020
In Commercial Distribution

  • 00840286832441 ()
2598-0-4020

  • Uncoated knee tibia prosthesis, metallic
6mm Tibial BP, Stemmed, Hole, No Peg, Half Wrap, L, 0, 0° Slope
Shalby Advanced Technologies, Inc.
2597-0-6020
In Commercial Distribution

  • 00840286831604 ()
2597-0-6020

  • Uncoated knee tibia prosthesis, metallic
4mm Tibial BP, Stemmed, Hole, No Peg, Half Wrap, L, 0, 0° Slope
Shalby Advanced Technologies, Inc.
2597-0-4020
In Commercial Distribution

  • 00840286830768 ()
2597-0-4020

  • Uncoated knee tibia prosthesis, metallic
6mm Tibial BP, Stemmed, Hole, No Peg, Full Wrap, R, 0, 0° Slope
Shalby Advanced Technologies, Inc.
2596-0-6020
In Commercial Distribution

  • 00840286829922 ()
2596-0-6020

  • Uncoated knee tibia prosthesis, metallic
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