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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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ION AO Coupling Handle - 00850040139990

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-5004
In Commercial Distribution

  • 00850040139990 ()


  • Spinal bone screw, bioabsorbable

Site Prep Barbed Guide +2mm Shim - 00850040139624

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6222
In Commercial Distribution

  • 00850040139624 ()


  • Spinal bone screw, bioabsorbable

Site Prep Barbed Guide +4mm Shim - 00850040139617

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6221
In Commercial Distribution

  • 00850040139617 ()


  • Spinal bone screw, bioabsorbable

Site Prep Barbed Guide - 00850040139600

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6220
In Commercial Distribution

  • 00850040139600 ()


  • Spinal bone screw, bioabsorbable

Site Prep Impactor - 00850040139594

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6201
In Commercial Distribution

  • 00850040139594 ()


  • Spinal bone screw, bioabsorbable

Site Prep Removal Tool - 00850040139464

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6230
In Commercial Distribution

  • 00850040139464 ()


  • Spinal bone screw, bioabsorbable

Site Prep Locator - Flat Series - 00850040139426

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6212
In Commercial Distribution

  • 00850040139426 ()


  • Spinal bone screw, bioabsorbable

Site Prep Locator - Teeth Series - 00850040139419

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6211
In Commercial Distribution

  • 00850040139419 ()


  • Spinal bone screw, bioabsorbable

Site Prep Rasp - 00850040139396

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6200
In Commercial Distribution

  • 00850040139396 ()


  • Spinal bone screw, bioabsorbable

Removal Sleeve - 00850040139143

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6024
In Commercial Distribution

  • 00850040139143 ()


  • Spinal bone screw, bioabsorbable
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