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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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BoneSeal 3.5 gram Ingot - 00858439001514

The Hemostasis BoneSeal Bone Hemostat stops bone bleeding by establishing a physical barrier along the edges of bones that have been damaged by trauma or cut during a surgical procedure. When applied as directed, BoneSeal forms a mechanical barrier that occludes the vascular openings in the damaged bone. This barrier prevents further bleeding during the surgical procedure. BoneSeal is based upon known biodegradable polymeric chemistry that forms a ready-to-use hemostatic agent. BoneSeal is available as a bone hemostat ingot of various masses. The bone hemostat ingot can be molded and formed by the surgeon to fit the damaged bone and applied to the bleeding area.
HEMOSTASIS, LLC
9550034
In Commercial Distribution

  • 00858439001514 ()
  • 00858439001521 ()

  • Weight: 3.5 Gram


  • Bone wax, synthetic

ION implant caddy small - 00858406007891

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

  • 00858406007891 ()


  • 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

5.0mm Drill Bit - 00858406007747

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6010
In Commercial Distribution

  • 00858406007747 ()


  • Spinal bone screw, bioabsorbable

5.5mm Drill Bit - 00858406007723

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6009
In Commercial Distribution

  • 00858406007723 ()


  • Spinal bone screw, bioabsorbable

4.5mm Drill Bit - Long - 00858406007594

SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6011
In Commercial Distribution

  • 00858406007594 ()


  • Spinal bone screw, bioabsorbable
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