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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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HEXAGONAL PROSTHETIC DRIVER
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.137
In Commercial Distribution

  • 07899878027355 ()
105.137

  • Dental implant system
GM IMPLANT DRIVER - CONTRA-ANGLE
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.131
In Commercial Distribution

  • 07899878023531 ()
105.131

  • Dental implant system
GM IMPLANT DRIVER - TORQUE WRENCH (LONG)
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.130
In Commercial Distribution

  • 07899878023524 ()
105.130

  • Dental implant system
GM IMPLANT DRIVER - TORQUE WRENCH (SHORT)
JJGC Indústria e Comércio de Materiais Dentários S/A.
105.129
In Commercial Distribution

  • 07899878023517 ()
105.129

  • Dental implant system
ALVIM GUIDED SURGERY BONE TAP DRIVER
JJGC Indústria e Comércio de Materiais Dentários S/A.
125.098
In Commercial Distribution

  • 07899878022831 ()

  • Outer Diameter: 3.5 Millimeter
  • Outer Diameter: 4.3 Millimeter
125.098

  • Surgical drill guide, reusable
SURGICAL HAMMER
JJGC Indústria e Comércio de Materiais Dentários S/A.
126.001
In Commercial Distribution

  • 07899878010609 ()
126.001

  • Surgical mallet
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
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290308
In Commercial Distribution

  • 00819824023979 ()
30290308

  • Surgical screwdriver, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290316
In Commercial Distribution

  • 00819824023894 ()
30290316

  • Orthopaedic inorganic implant inserter/extractor, reusable
THE XULTAN 5.5 PEDICLE SCREW SYSTEM IS AN IMPLANT DEVICE MANUFACTURED FROM TITANIUM AND SILICONE. THE SCREWS ARE AVAILABLE CANNULATED OR NON-CANNULATED IN VARIOUS DIAMETERS AND LENGTHS TO ACCOMMODATE VARIOUS PATIENT ANATOMIES. THE SYSTEM INCLUDES STRAIGHT RODS, CURVED RODS, CROSSLINKS, AND ASSOCIATED INSTRUMENTATION.
MET 1 TECHNOLOGIES, LLC
30290313
In Commercial Distribution

  • 00819824023856 ()
30290313

  • Surgical screwdriver, reusable
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