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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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TWO LEVEL INSTRUMENT CASE (WITH CADDY)
Xtant Medical Holdings, Inc.
X085-0001
In Commercial Distribution

  • M697X08500010 ()
  • M697X08500011 ()


  • Spinal fixation plate, non-bioabsorbable
Henry ScheinĀ® Root Canal Liquid, 3.5mL Bottle
DENTSPLY INTERNATIONAL INC.
1711435FG
Not in Commercial Distribution

  • D6871711435FG2 ()
  • D6871711435FG0 ()

  • One 1/ 8 oz (3.5mL) Bottle
  • Total Volume: 3.5 Milliliter
1711435FG

  • Hygroscopic dental cement
Neuro Caliper
Xtant Medical Holdings, Inc.
N60000482
In Commercial Distribution

  • M697N600004820 ()
  • M697N600004821 ()


  • Spinal fixation plate, non-bioabsorbable
Sterilization Case, Spider System
Xtant Medical Holdings, Inc.
N60000201
In Commercial Distribution

  • M697N600002010 ()
  • M697N600002011 ()


  • Spinal fixation plate, non-bioabsorbable
Plate Bender
Xtant Medical Holdings, Inc.
N60000192
In Commercial Distribution

  • M697N600001920 ()
  • M697N600001921 ()


  • Spinal fixation plate, non-bioabsorbable
Screw Removal Device
Xtant Medical Holdings, Inc.
N60000190
In Commercial Distribution

  • M697N600001900 ()
  • M697N600001901 ()


  • Spinal fixation plate, non-bioabsorbable
Single Barrel Variable Drill Guide Assembly
Xtant Medical Holdings, Inc.
N60000180
In Commercial Distribution

  • M697N600001800 ()
  • M697N600001801 ()


  • Spinal fixation plate, non-bioabsorbable
3-sided Silicone Handle w/ AO Connector
Xtant Medical Holdings, Inc.
N60000178
Not in Commercial Distribution

  • M697N600001780 ()
  • M697N600001781 ()


  • Spinal fixation plate, non-bioabsorbable
16mm Drill Bit
Xtant Medical Holdings, Inc.
N60000177
In Commercial Distribution

  • M697N600001770 ()
  • M697N600001771 ()

  • Length: 16 Millimeter


  • Spinal fixation plate, non-bioabsorbable
14mm Drill Bit
Xtant Medical Holdings, Inc.
N60000176
In Commercial Distribution

  • M697N600001760 ()
  • M697N600001761 ()

  • Length: 14 Millimeter


  • Spinal fixation plate, non-bioabsorbable
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