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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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FIXCET COMPRESSION SCREW, 4.5 x 30MM DUAL THREAD
Xtant Medical Holdings, Inc.
X063-0005
In Commercial Distribution

  • M697X06300051 ()

  • Outer Diameter: 30 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
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
K-Wire, .054 Trocar End, 500mm
Xtant Medical Holdings, Inc.
X063-0063
In Commercial Distribution

  • M697X06300630 ()
  • M697X06300631 ()

  • Length: 500 Millimeter
  • Outer Diameter: 0.054 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
K-Wire, .054 Trocar End, 350mm
Xtant Medical Holdings, Inc.
X063-0062
In Commercial Distribution

  • M697X06300620 ()
  • M697X06300621 ()

  • Outer Diameter: 0.054 Millimeter
  • Length: 350 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
K-Wire, .054 Trocar End, 250mm
Xtant Medical Holdings, Inc.
X063-0060
In Commercial Distribution

  • M697X06300600 ()
  • M697X06300601 ()

  • Length: 250 Millimeter
  • Outer Diameter: 0.054 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable
ASSEMBLY, DILATOR HANDLE
Xtant Medical Holdings, Inc.
X063-0045
In Commercial Distribution

  • M697X06300450 ()
  • M697X06300451 ()


  • Orthopaedic implantation sleeve, reusable
OUTER DILATOR, SS, 12mm x 7.25"
Xtant Medical Holdings, Inc.
X063-0036
In Commercial Distribution

  • M697X06300360 ()
  • M697X06300361 ()

  • Outer Diameter: 12 Millimeter
  • Length: 7.25 Inch


  • 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
Resorbable Collagen Dental Wound Dressing
KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.
RCWT0001
In Commercial Distribution

  • 00842517100084 ()
  • 00842517100077 ()

  • 2.5 cm Width 7.5 cm Length 3mm Thick


  • General oral wound dressing, animal-derived
Resorbable Collagen Dental Wound Dressing
KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.
RCWP0001
In Commercial Distribution

  • 00842517100060 ()
  • 00842517100053 ()

  • 1 cm Width 2 cm Length


  • General oral wound dressing, animal-derived
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