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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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ORTHOMED - B8034606560

MALLET #49 7 OZ/5 OZ
ORTHO-MED, INC.
OM 46-0656
In Commercial Distribution

  • B8034606560 ()


  • Surgical mallet

XULTAN CROSSLINK DRIVER - 00819824023986

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
30290309
In Commercial Distribution

  • 00819824023986 ()
30290309

  • Surgical screwdriver, reusable

XULTAN CROSSLINK DRIVER THREADED SHAFT - 00819824023979

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

XULTAN CROSSLINK DRIVER REMOVAL TOOL - 00819824023894

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

XULTAN DOUBLE ENDED BLOCKER DRIVER - 00819824023856

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

XULTAN NON LOCKING REDUCTION DRIVER - 00819824023832

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
30290332
In Commercial Distribution

  • 00819824023832 ()
30290332

  • Surgical screwdriver, reusable

XULTAN NON LOCKING DRIVER - 00819824023825

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

XULTAN CROSSLINK FINAL DRIVER - 00819824023788

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
300290347
In Commercial Distribution

  • 00819824023788 ()
30290347

  • Surgical screwdriver, reusable

XULTAN CROSSLINK DRIVER REMOVAL TOOL - 00819824023757

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
30290348
In Commercial Distribution

  • 00819824023757 ()
30290348

  • Orthopaedic inorganic implant inserter/extractor, reusable

XULTAN CROSSLINK DRIVER HANDLE - 00819824023740

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
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