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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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Pin Puller - 00858406007945

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-5003
In Commercial Distribution

  • 00858406007945 ()


  • Spinal bone screw, bioabsorbable

ION implant caddy large - 00858406007907

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-7006
In Commercial Distribution

  • 00858406007907 ()


  • Spinal bone screw, bioabsorbable

ION implant caddy small - 00858406007891

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-7003
In Commercial Distribution

  • 00858406007891 ()


  • Spinal bone screw, bioabsorbable

ION Sterilization Tray - 00858406007884

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-7007
In Commercial Distribution

  • 00858406007884 ()


  • Spinal bone screw, bioabsorbable

Facet Screw Drill Guide - 00858406007860

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6006
In Commercial Distribution

  • 00858406007860 ()


  • Spinal bone screw, bioabsorbable

Plastic Drill Guide - 00858406007839

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6002
In Commercial Distribution

  • 00858406007839 ()


  • Spinal bone screw, bioabsorbable

4.5mm Drill Bit - Facet Screw - 00858406007815

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6008
In Commercial Distribution

  • 00858406007815 ()


  • Spinal bone screw, bioabsorbable

5.5mm Drill Bit - Long - 00858406007808

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6013
In Commercial Distribution

  • 00858406007808 ()


  • Spinal bone screw, bioabsorbable

5.0mm Drill Bit - Long - 00858406007792

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6012
In Commercial Distribution

  • 00858406007792 ()


  • Spinal bone screw, bioabsorbable

Facet Screw Inserter - 00858406007778

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6001
In Commercial Distribution

  • 00858406007778 ()


  • Spinal bone screw, bioabsorbable
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