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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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SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-5000
In Commercial Distribution

  • 00858406007761 ()


  • Spinal bone screw, bioabsorbable
SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6010
In Commercial Distribution

  • 00858406007747 ()


  • Spinal bone screw, bioabsorbable
SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6009
In Commercial Distribution

  • 00858406007723 ()


  • Spinal bone screw, bioabsorbable
SR12- ION Facet Screw System
SURGENTEC, LLC
SR12-6011
In Commercial Distribution

  • 00858406007594 ()


  • Spinal bone screw, bioabsorbable
No Description
SURGENTEC, LLC
FC-G-16
In Commercial Distribution

  • 00858406007587 ()


  • Spinal guidewire
No Description
SURGENTEC, LLC
FC-G-16S
In Commercial Distribution

  • 00858406007570 ()


  • Spinal guidewire
No Description
SURGENTEC, LLC
FC-D-45
In Commercial Distribution

  • 00858406007495 ()


  • Fluted surgical drill bit, reusable
The Korebalance® is designed for use by medical centers and clinics, medical and PT offices, assisted living facilities recreation centers, health and fitness clubs, universities, and professional sports teams. The Korebalance® System uses the latest in interactive technology, offering innovative high-tech balance assessment and training. Backed by over two decades of medical experience, the Korebalance® will provide you and your patients with the best possible documented neurosensory assessment and training.
Diversified Healthcare Development, LLC
KB01
In Commercial Distribution

  • 00858458007009 ()


  • Balance/cognitive function analysis system
ExcelArrest XT (EAXT) is a single use, sterile, dry chitosan-based foam hemostat. EAXT is offered as compressed foam pads in sterile barrier pouches.
HEMOSTASIS, LLC
9210223
Not in Commercial Distribution

  • 00858439001705 ()
  • 00858439001699 ()

  • Width: 2 Inch
  • Length: 2 Inch


  • Chitosan haemostatic agent, professional, non-bioabsorbable
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
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