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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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Carbon Fiber Facet Locator
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF10010 ()
NF-1001

  • External spinal fixation system
Carbon Fiber Handle
Nutech Spine, Inc.
IR
In Commercial Distribution

  • B946NF10060 ()
NF-1006

  • External spinal fixation system
Medfix Distraction Screw Driver 8" (200mm)
NEXUS SPINE, L.L.C.
821083.09
Not in Commercial Distribution

  • B678821083090 ()


  • Spinal fixation plate, non-bioabsorbable
Medfix® Distraction Screw Driver 8" (200mm)
NEXUS SPINE, L.L.C.
821081.09
Not in Commercial Distribution

  • B678821081090 ()


  • Spinal fixation plate, non-bioabsorbable
2.5MM HEX DRIVER
OPTIMOTION IMPLANTS LLC
1014-2-0035
In Commercial Distribution

  • B6961014200350 ()


  • Cruciate-retaining total knee prosthesis
Temporary Fixation Screw, 2.5 x 10mm
CURITEVA, INC.
C155-300-10
In Commercial Distribution

  • B648C155300100 ()

  • Outer Diameter: 2.5 Millimeter
  • Length: 10 Millimeter


  • External spinal fixation system
THE MET ONE CZAR ANTERIOR CERVICAL PLATE SYSTEM IS INTENDED FOR ANTERIOR INTERBODY SCREW FIXATION OF THE CERVICAL SPINE. THE SYSTEM INCLUDES SCREWS, PLATES, AND A SET OF INSTRUMENTS TO INSERT THE IMPLANTS. PLATES ARE AVAILABLE IN A VARIETY OF LENGTHS TO ACCOMODATE FUSION PROCEDURES FROM ONE TO FOUR LEVELS OF THE CERVICAL SPINE. FIXATION IS ACHIEVED BY INSERTING THE SCREWS THROUGH THE OPENINGS IN THE PLATE INTO VERTEBRAL BODIES OF THE CERVICAL SPINE. THE PLATES ARE MANUFACTURED FROM TITANIUM 6 A1-4V ELI PER ASTM F136 AND INVIBIO PEEK-OPTIMA LT1 PER ASTM F2026.
MET 1 TECHNOLOGIES, LLC
66000008
In Commercial Distribution

  • 00819824025034 ()
66000008

  • Spinal fixation plate, non-bioabsorbable
NGS GM REGULAR DRIVER FOR TORQUE WRENCH
JJGC Indústria e Comércio de Materiais Dentários S/A.
105164
In Commercial Distribution

  • 07899878046912 ()

  • Outer Diameter: 5 Millimeter
105.164

  • Dental implant system
NGS GM REGULAR DRIVER FOR CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105163
In Commercial Distribution

  • 07899878046905 ()

  • Outer Diameter: 1.2 Millimeter
105.163

  • Dental implant system
NGS GM NARROW DRIVER FOR TORQUE WRENCH
JJGC Indústria e Comércio de Materiais Dentários S/A.
105162
In Commercial Distribution

  • 07899878046899 ()

  • Outer Diameter: 5 Millimeter
105.162

  • Dental implant system
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