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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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Hyflex - D661H82506301

Hyflex CM 06/30 x 25mm File
COLTENE/WHALEDENT INC
H8250630
In Commercial Distribution

  • D661H82506301 ()
  • D661H82506300 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H82504301

Hyflex CM 04/30 x 25mm File
COLTENE/WHALEDENT INC
H8250430
In Commercial Distribution

  • D661H82504301 ()
  • D661H82504300 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H82106301

Hyflex CM 06/30 x 21mm File
COLTENE/WHALEDENT INC
H8210630
In Commercial Distribution

  • D661H82106301 ()
  • D661H82106300 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H82104301

Hyflex CM 04/30 x 21mm File
COLTENE/WHALEDENT INC
H8210430
In Commercial Distribution

  • D661H82104301 ()
  • D661H82104300 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H084021

Hyflex X-File NT #30 x 25mm File
COLTENE/WHALEDENT INC
H08402
Not in Commercial Distribution

  • D661H084021 ()
  • D661H084020 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Hyflex - D661H083801

Hyflex X-File NT #30 x 21mm File
COLTENE/WHALEDENT INC
H08380
Not in Commercial Distribution

  • D661H083801 ()
  • D661H083800 ()


  • Rotary/reciprocating endodontic file/rasp, reusable

Fortex Pedicle Screw System - M697X06400251

Assembly, Fortex, 8.25 x 30 Reduction Screw
Xtant Medical Holdings, Inc.
X064-0025
In Commercial Distribution

  • M697X06400251 ()

  • Length: 30 Millimeter
  • Outer Diameter: 8.25 Millimeter


  • Spinal bone screw, non-bioabsorbable

Fortex Pedicle Screw System - M697X06400191

Assembly, Fortex, 7.5 x 30 Reduction Screw
Xtant Medical Holdings, Inc.
X064-0019
In Commercial Distribution

  • M697X06400191 ()

  • Length: 30 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Fortex Pedicle Screw System - M697X06400131

Assembly, Fortex, 6.5 x 30 Reduction Screw
Xtant Medical Holdings, Inc.
X064-0013
In Commercial Distribution

  • M697X06400131 ()

  • Length: 30 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Spinal bone screw, non-bioabsorbable

Fortex Pedicle Screw System - M697X06400071

Assembly, Fortex, 5.5 x 30 Reduction Screw
Xtant Medical Holdings, Inc.
X064-0007
In Commercial Distribution

  • M697X06400071 ()

  • Length: 30 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
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