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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TAP EX1011161 5.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011161
In Commercial Distribution

  • 00643169096370 ()


  • Bone tap, reusable
TAP EX1011160 5.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011160
In Commercial Distribution

  • 00643169096363 ()


  • Bone tap, reusable
TAP EX1011159 4.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011159
In Commercial Distribution

  • 00643169096356 ()


  • Bone tap, reusable
TAP EX1011158 4.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011158
In Commercial Distribution

  • 00643169096349 ()


  • Bone tap, reusable
CURETTE THICK EX0811001 1.8 STR
MEDTRONIC SOFAMOR DANEK, INC.
EX0811001
In Commercial Distribution

  • 00643169096318 ()


  • Bone curette, reusable
DRIVER EX1011188 T25 TWIST STAB AND GRAB
MEDTRONIC SOFAMOR DANEK, INC.
EX1011188
In Commercial Distribution

  • 00643169095861 ()


  • Surgical drill guide, reusable
RETRACTOR EX1011177 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1011177
In Commercial Distribution

  • 00643169095854 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX1011176 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX1011176
In Commercial Distribution

  • 00643169095847 ()


  • Surgical retractor/retraction system blade, reusable
DRILL GUIDE EX1011148 GENERAL SS
MEDTRONIC SOFAMOR DANEK, INC.
EX1011148
In Commercial Distribution

  • 00643169094277 ()


  • Surgical drill guide, reusable
DRIVER X1011135 6.35 REDUCTION NUT
MEDTRONIC SOFAMOR DANEK, INC.
X1011135
In Commercial Distribution

  • 00643169094260 ()


  • Orthopaedic implant driver
REDUCER X1011005 SEQUENTIAL 6.35 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X1011005
In Commercial Distribution

  • 00643169094253 ()


  • Orthopaedic rod reducer
STARTER EX1011118 FLEXIBLE PLUG
MEDTRONIC SOFAMOR DANEK, INC.
EX1011118
In Commercial Distribution

  • 00643169092471 ()


  • Orthopaedic instrument surgical connector
AWL EX1011020 SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX1011020
In Commercial Distribution

  • 00643169092464 ()


  • Bone awl, reusable
SHAVER/DISTRACTOR EX0911200 13MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0911200
In Commercial Distribution

  • 00643169092075 ()


  • Orthopaedic surgical distractor, internal
SHAVER/DISTRACTOR EX0911199 12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0911199
In Commercial Distribution

  • 00643169092068 ()


  • Orthopaedic surgical distractor, internal
SHAVER/DISTRACTOR EX0911198 11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0911198
In Commercial Distribution

  • 00643169092051 ()


  • Orthopaedic surgical distractor, internal
SHAVER/DISTRACTOR EX0911197 7MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0911197
In Commercial Distribution

  • 00643169092044 ()


  • Orthopaedic surgical distractor, internal
CHISEL EX1011046 GENERAL SS
MEDTRONIC SOFAMOR DANEK, INC.
EX1011046
In Commercial Distribution

  • 00643169091955 ()


  • Orthopaedic osteotome
PIN DISTRACTOR EX0911144 DUAL OPEN
MEDTRONIC SOFAMOR DANEK, INC.
EX0911144
In Commercial Distribution

  • 00643169091948 ()


  • Orthopaedic surgical distractor, internal
SHAFT 3990004 SHORT THREADED
MEDTRONIC SOFAMOR DANEK, INC.
3990004
In Commercial Distribution

  • 00643169091474 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
INSERTER 3990001 LONG GRASPING
MEDTRONIC SOFAMOR DANEK, INC.
3990001
In Commercial Distribution

  • 00643169091450 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
SHAFT 3990002 LONG THREADED
MEDTRONIC SOFAMOR DANEK, INC.
3990002
In Commercial Distribution

  • 00643169091443 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
INSERTER 3990003 SHORT GRASPING
MEDTRONIC SOFAMOR DANEK, INC.
3990003
In Commercial Distribution

  • 00643169091436 ()


  • Orthopaedic implantation sleeve, reusable
FEELER PROBE EX0911073 LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0911073
In Commercial Distribution

  • 00643169091405 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
OBTURATOR EX1011004 FOR PROBE X0407374
MEDTRONIC SOFAMOR DANEK, INC.
EX1011004
In Commercial Distribution

  • 00643169091023 ()


  • Surgical instrument handle, non-torque-limiting
HEX DRIVER EX0410300 EXPANDABLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0410300
In Commercial Distribution

  • 00643169090828 ()


  • Orthopaedic implant driver
PIN DRIVER EX0911146 EXTENDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0911146
In Commercial Distribution

  • 00643169090811 ()


  • Surgical drill guide, reusable
AWL EX0911145 LONG TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0911145
In Commercial Distribution

  • 00643169090804 ()


  • Bone awl, reusable
BONE FUNNEL EX1011016 BEVELED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011016
In Commercial Distribution

  • 00643169090149 ()


  • Bone graft funnel
GUIDE EX0911128 SINGLE BARREL DTS
MEDTRONIC SOFAMOR DANEK, INC.
EX0911128
In Commercial Distribution

  • 00643169089587 ()


  • General internal orthopaedic fixation system implantation kit
PROBE EX0811539 BLUNT TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0811539
In Commercial Distribution

  • 00643169089570 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
DRIVER EX0911232 NON-BREAK OFF WHANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0911232
In Commercial Distribution

  • 00643169089488 ()


  • Orthopaedic implant driver
WRENCH X0911158 32MM OPEN END
MEDTRONIC SOFAMOR DANEK, INC.
X0911158
In Commercial Distribution

  • 00643169089204 ()


  • Surgical torque wrench, reusable
RETRACTOR/LEVER EX0911035 HAND HELD
MEDTRONIC SOFAMOR DANEK, INC.
EX0911035
In Commercial Distribution

  • 00643169089198 ()


  • Surgical instrument handle, non-torque-limiting
POSITIONER EX0911187 NO-STOP
MEDTRONIC SOFAMOR DANEK, INC.
EX0911187
In Commercial Distribution

  • 00643169089174 ()


  • Bone graft packing block
POSITIONER EX0911186 3MM-STOP
MEDTRONIC SOFAMOR DANEK, INC.
EX0911186
In Commercial Distribution

  • 00643169089167 ()


  • Bone graft packing block
ELEVATOR EX0911185 FACET 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0911185
In Commercial Distribution

  • 00643169089150 ()


  • Bone lever/elevator, reusable
ELEVATOR EX0911184 FACET 5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0911184
In Commercial Distribution

  • 00643169089143 ()


  • Bone lever/elevator, reusable
ELEVATOR EX0911183 FACET 3MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0911183
In Commercial Distribution

  • 00643169089136 ()


  • Bone lever/elevator, reusable
RASP EX0911182 STRAIGHT 4MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0911182
In Commercial Distribution

  • 00643169089129 ()


  • Bone file/rasp, manual, reusable
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