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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INNER DILATOR, SS, 8mm
Xtant Medical Holdings, Inc.
X063-0035
In Commercial Distribution

  • M697X06300350 ()
  • M697X06300351 ()

  • Outer Diameter: 8 Millimeter


  • Orthopaedic implantation sleeve, reusable
DRILL BIT, 2 FLUTE, NON-CANNULATED
Xtant Medical Holdings, Inc.
X063-0031
In Commercial Distribution

  • M697X06300310 ()
  • M697X06300311 ()


  • Fluted surgical drill bit, reusable
TAP SHAFT
Xtant Medical Holdings, Inc.
X063-0029
In Commercial Distribution

  • M697X06300290 ()
  • M697X06300291 ()


  • Bone tap, reusable
FIXCET SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
X063-0025
In Commercial Distribution

  • M697X06300250 ()
  • M697X06300251 ()


  • Surgical screwdriver, reusable
Sodium Hypochlorite Solution 16 oz.
DENTSPLY INTERNATIONAL INC.
0011507FG
In Commercial Distribution

  • D6870011507FG2 ()
  • D6870011507FG0 ()

  • 12 Bottles (16 oz/473mL)
  • Total Volume: 473 Milliliter
0011507FG

  • Root canal cleaning solution
Lip Clip (Set of 5)
COLTENE/WHALEDENT INC
60018741
In Commercial Distribution

  • D661200047940 ()
  • D661600187410 ()


  • Endodontic apex locator
Touch Probe (Set of 2)
COLTENE/WHALEDENT INC
60018740
In Commercial Distribution

  • D661200047950 ()
  • D661600187400 ()


  • Endodontic apex locator
File Clips (Set of 2)
COLTENE/WHALEDENT INC
60018739
In Commercial Distribution

  • D661200047960 ()
  • D661600187390 ()


  • Endodontic apex locator
Specialty Luer Lock adapter for Osteosponge putty syringe
Xtant Medical Holdings, Inc.
C076-0006
In Commercial Distribution

  • M697C07600060 ()
  • M697C07600061 ()


  • General-purpose syringe, single-use
Specialty Luer Lock adapter for Osteosponge putty syringe
Xtant Medical Holdings, Inc.
C076-0005
In Commercial Distribution

  • M697C07600050 ()
  • M697C07600051 ()


  • General-purpose syringe, single-use
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