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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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Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
DRIVER EX0416035 5.5/6.0 FAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0416035
In Commercial Distribution

  • 00643169764194 ()


  • Surgical screwdriver, reusable
DRIVER EX0514021 TAPERED HEX 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0514021
In Commercial Distribution

  • 00643169523562 ()


  • Orthopaedic implant driver
DRIVER 8001201 HANDL MOD TIMESH
MEDTRONIC PS MEDICAL, INC.
8001201
In Commercial Distribution

  • 00643169497870 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER 8001205 MOD SHAFT 1.6MM
MEDTRONIC PS MEDICAL, INC.
8001205
In Commercial Distribution

  • 00643169497863 ()

  • Outer Diameter: 1.6 Millimeter


  • General internal orthopaedic fixation system implantation kit
Flexible IM Reamer Shaft 650mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1156
In Commercial Distribution

  • 05391529588700 ()

  • 3.2 x 227.0mm
INS-1156

  • Medullary canal orthopaedic reamer shaft
Flexible Hex Driver Ball Tip (5mm/8mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1151
In Commercial Distribution

  • 05391529588656 ()

  • Ø7.92 x 195mm
INS-1151

  • Surgical screwdriver, reusable
Flexible IM reamer Shaft 470mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1095
In Commercial Distribution

  • 05391529583057 ()

  • 470.0 mm
INS-1095

  • Medullary canal orthopaedic reamer shaft
Long Screw Hex Driver (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1078
In Commercial Distribution

  • 05391529582883 ()
INS-1078

  • Surgical screwdriver, reusable
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