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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 2x2.5 gram Ingot - 00858439001552

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
9550074
Not in Commercial Distribution

  • 00858439001569 ()
  • 00858439001552 ()

  • Weight: 5.0 Gram


  • Bone wax, synthetic

ION Facet Screw System - 00858406007990

ION Facet Screw - 5.5 x 45mm
SURGENTEC, LLC
TI-AE-55-45
In Commercial Distribution

  • 00858406007990 ()


  • Trans-facet-screw internal spinal fixation system, sterile

ION Facet Screw System - 00858406007983

ION Facet Screw - 5.5 x 35mm
SURGENTEC, LLC
TI-AE-55-35
In Commercial Distribution

  • 00858406007983 ()


  • Trans-facet-screw internal spinal fixation system, sterile

ION Facet Screw System - 00858406007976

ION Facet Screw - 5.5 x 25mm
SURGENTEC, LLC
TI-AE-55-25
In Commercial Distribution

  • 00858406007976 ()


  • Trans-facet-screw internal spinal fixation system, sterile

ION Facet Screw System - 00858406007969

ION Facet Screw - 5.5 x 15mm
SURGENTEC, LLC
TI-AE-55-15
In Commercial Distribution

  • 00858406007969 ()


  • Trans-facet-screw internal spinal fixation system, sterile

ION Facet Screw System - 00858406007952

ION Facet Screw - 5.5 x 10mm
SURGENTEC, LLC
TI-AE-55
In Commercial Distribution

  • 00858406007952 ()


  • Trans-facet-screw internal spinal fixation system, sterile

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 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
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