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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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Plastic Drill Guide Non-Cervical - 00810131880880

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6302
In Commercial Distribution

  • 00810131880880 ()


  • Spinal bone screw, bioabsorbable

5.0mm Drill Bit - Non-Cervical - 00810131880866

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6310
In Commercial Distribution

  • 00810131880866 ()


  • Spinal bone screw, bioabsorbable

ION AO Coupling Cannulated Handle - 00810131880392

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-5006
In Commercial Distribution

  • 00810131880392 ()


  • Spinal bone screw, bioabsorbable

ION AO Coupling Big Handle - 00810131880033

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-5005
In Commercial Distribution

  • 00810131880033 ()


  • Spinal bone screw, bioabsorbable

Impactor 7mm - 00810131881399

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6101
In Commercial Distribution

  • 00810131881399 ()


  • Spinal bone screw, bioabsorbable

Facet Locator - 7.0mm - 00810131881245

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6007
In Commercial Distribution

  • 00810131881245 ()


  • Spinal bone screw, bioabsorbable

Plastic Circular Decortication Rasp - 00810131881238

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6320
In Commercial Distribution

  • 00810131881238 ()


  • Spinal bone screw, bioabsorbable

5.5mm Drill Bit - Non-Cervical - 00810131880873

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6309
In Commercial Distribution

  • 00810131880873 ()


  • Spinal bone screw, bioabsorbable

4.5mm Drill Bit - Non-Cervical - 00810131880859

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6308
In Commercial Distribution

  • 00810131880859 ()


  • Spinal bone screw, bioabsorbable

ION AO Coupling Cannulated Handle - Solco - 00810131880538

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-5007
In Commercial Distribution

  • 00810131880538 ()


  • Spinal bone screw, bioabsorbable
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