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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 Lumbar Integrated Fusion System - M697X08038281924PCSTR1

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 Lumbar Integrated Fusion System - M697X08038281724PCSTR1

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 Lumbar Integrated Fusion System - M697X08033261924PCSTR1

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 Lumbar Integrated Fusion System - M697X08033261724PCSTR1

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

AMT MiniSPC Drainage Set - 00842071148355

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

CKS Plus - 00840286833288

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

CKS Plus - 00840286832441

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

CKS Plus - 00840286831604

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

CKS Plus - 00840286830768

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

CKS Plus - 00840286829922

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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