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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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Ortho-Cast M-Series 18, Buccal tubes, -20°T.,0°O.,conv.,36-37
DENTAURUM GmbH & Co.KG
818-152-30
In Commercial Distribution

  • J011818152300 ()
  • J011818152301 ()


  • Orthodontic bracket, metal
IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-20T-STR
In Commercial Distribution

  • M697X08042301920TSTR1 ()

  • 30mm depth X 20°, 19mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 20°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423019-20-STR
In Commercial Distribution

  • M697X08042301920STR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 20°, 19mm height


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423017-20T-STR
In Commercial Distribution

  • M697X08042301720TSTR1 ()

  • Width: 42 Millimeter
  • 30mm depth X 20°, 17mm height


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 42 X 30 X 20°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423017-20-STR
In Commercial Distribution

  • M697X08042301720STR1 ()

  • 30mm depth X 20°, 17mm height
  • Width: 42 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 15mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423015-20T-STR
In Commercial Distribution

  • M697X08042301520TSTR1 ()

  • 30mm depth X 20°, 15mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM, 42 X 30 X 20°, 13mm (STERILE)
Xtant Medical Holdings, Inc.
X080-423013-20T-STR
In Commercial Distribution

  • M697X08042301320TSTR1 ()

  • 30mm depth X 20°, 13mm height
  • Width: 42 Millimeter


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-20T-STR
In Commercial Distribution

  • M697X08038281920TSTR1 ()

  • 28mm depth X 20°, 19mm height
  • Width: 38 Millimeter


  • Metallic spinal interbody fusion cage
IRIX-A INTEGRATED SPACER ASSY, 38 X 28 X 20°, 19mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382819-20-STR
In Commercial Distribution

  • M697X08038281920STR1 ()

  • 28mm depth X 20°, 19mm height
  • Width: 38 Millimeter


  • Metal-polymer composite spinal interbody fusion cage
IRIX-A INTEGRATED SPACER, TITANIUM, 38 X 28 X 20°, 17mm (STERILE)
Xtant Medical Holdings, Inc.
X080-382817-20T-STR
In Commercial Distribution

  • M697X08038281720TSTR1 ()

  • Width: 38 Millimeter
  • 28mm depth X 20°, 17mm height


  • Metallic spinal interbody fusion cage
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