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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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Torque Limiting Hexalobe Driver, 8Nm
GLOBUS MEDICAL, INC.
6120.0041
In Commercial Distribution

  • 00889095358490 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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 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
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
30290317
In Commercial Distribution

  • 00819824023825 ()
30290317

  • 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
30290307
In Commercial Distribution

  • 00819824023740 ()
30290307

  • Surgical instrument handle, non-torque-limiting
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
30290326
In Commercial Distribution

  • 00819824023672 ()
30290326

  • Surgical instrument handle, torque-limiting
SCREW DRIVER HANDLE
BIONNOVATION PRODUTOS BIOMEDICOS LTDA.
13085
In Commercial Distribution

  • 07898628611073 ()
13085

  • Surgical torque wrench, reusable
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