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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PROBE EX0212019 STRAIGHT BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0212019
In Commercial Distribution

  • 00643169169654 ()


  • Surgical instrument handle, non-torque-limiting
TAP EX0212018 6.5MM DIA BLUNT TIP QC
MEDTRONIC SOFAMOR DANEK, INC.
EX0212018
In Commercial Distribution

  • 00643169169647 ()


  • Bone tap, reusable
TAP EX0212017 5.5MM DIA BLUNT TIP QC
MEDTRONIC SOFAMOR DANEK, INC.
EX0212017
In Commercial Distribution

  • 00643169169630 ()


  • Bone tap, reusable
TAP EX0212016 4.5MM DIA BLUNT TIP QC
MEDTRONIC SOFAMOR DANEK, INC.
EX0212016
In Commercial Distribution

  • 00643169169623 ()


  • Bone tap, reusable
COUNTER TORQUE EX0412019 CUTOUT OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
EX0412019
In Commercial Distribution

  • 00643169169555 ()


  • Orthopaedic counter-torque/rod-pushing instrument
PUSHER 5584235 5.5/6.0 ROD PUSHER - EU
MEDTRONIC SOFAMOR DANEK, INC.
5584235
In Commercial Distribution

  • 00643169169241 ()


  • Orthopaedic counter-torque/rod-pushing instrument
DILATOR EX0312015 EXTENDED 5.3MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0312015
In Commercial Distribution

  • 00643169169234 ()


  • Laparoscopic access cannula dilator
TAP EX0312669 6.5MM SHORT THREAD
MEDTRONIC SOFAMOR DANEK, INC.
EX0312669
In Commercial Distribution

  • 00643169169227 ()


  • Bone tap, reusable
TAP EX0312668 5.5MM SHORT THREAD
MEDTRONIC SOFAMOR DANEK, INC.
EX0312668
In Commercial Distribution

  • 00643169169210 ()


  • Bone tap, reusable
RETRACTOR EX02121233 MALLEABLE 16MM
MEDTRONIC SOFAMOR DANEK, INC.
EX02121233
In Commercial Distribution

  • 00643169167810 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX02121232 MALLEABLE 12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX02121232
In Commercial Distribution

  • 00643169167803 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX02121231 MALLEABLE 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX02121231
In Commercial Distribution

  • 00643169167797 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0112133 NERVE ROOT 12.7MM
MEDTRONIC SOFAMOR DANEK, INC.
X0112133
In Commercial Distribution

  • 00643169167315 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0112132 NERVE ROOT 9.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0112132
In Commercial Distribution

  • 00643169167308 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0112131 NERVE ROOT 6.35MM
MEDTRONIC SOFAMOR DANEK, INC.
X0112131
In Commercial Distribution

  • 00643169167292 ()


  • Surgical retractor/retraction system blade, reusable
TUBE EX0312197 80MM LEFT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312197
In Commercial Distribution

  • 00643169167254 ()


  • Bone graft funnel
TUBE EX0312196 70MM LEFT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312196
In Commercial Distribution

  • 00643169167247 ()


  • Bone graft funnel
TUBE EX0312195 60MM LEFT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312195
In Commercial Distribution

  • 00643169167230 ()


  • Bone graft funnel
TUBE EX0312194 50MM LEFT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312194
In Commercial Distribution

  • 00643169167223 ()


  • Bone graft funnel
TUBE EX0312193 40MM LEFT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312193
In Commercial Distribution

  • 00643169167216 ()


  • Bone graft funnel
TUBE EX0312192 80MM RIGHT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312192
In Commercial Distribution

  • 00643169167209 ()


  • Bone graft funnel
TUBE EX0312191 70MM RIGHT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312191
In Commercial Distribution

  • 00643169167193 ()


  • Bone graft funnel
TUBE EX0312190 60MM RIGHT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312190
In Commercial Distribution

  • 00643169167186 ()


  • Bone graft funnel
TUBE EX0312189 50MM RIGHT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312189
In Commercial Distribution

  • 00643169167179 ()


  • Bone graft funnel
TUBE EX0312188 40MM RIGHT HALF BLACK
MEDTRONIC SOFAMOR DANEK, INC.
EX0312188
In Commercial Distribution

  • 00643169167162 ()


  • Bone graft funnel
HOOK HOLDER EX0312468 FORCEP
MEDTRONIC SOFAMOR DANEK, INC.
EX0312468
In Commercial Distribution

  • 00643169167155 ()


  • General internal orthopaedic fixation system implantation kit
TAP EX0312464 DUAL 7.5MM - PEAR HANDLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0312464
In Commercial Distribution

  • 00643169167148 ()


  • Bone tap, reusable
TAP EX0312463 DUAL 6.5MM - PEAR HANDLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0312463
In Commercial Distribution

  • 00643169167131 ()


  • Bone tap, reusable
TAP EX0312462 DUAL 5.5MM - PEAR HANDLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0312462
In Commercial Distribution

  • 00643169167124 ()


  • Bone tap, reusable
DRIVER EX0212740 3.2MM BALL TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0212740
In Commercial Distribution

  • 00643169167117 ()


  • Orthopaedic implant driver
DRILL GUIDE EX0312059 FIXED 17MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0312059
In Commercial Distribution

  • 00643169166783 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX0312058 FIXED 15MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0312058
In Commercial Distribution

  • 00643169166776 ()


  • Surgical drill guide, reusable
TAMP EX0312051 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0312051
In Commercial Distribution

  • 00643169166769 ()


  • Surgical tamp, reusable
DRIVER EX0312093 T-27 EXTENDED SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0312093
In Commercial Distribution

  • 00643169165601 ()


  • Surgical drill guide, reusable
OBLIQUE EX02121227 16MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
EX02121227
In Commercial Distribution

  • 00643169165564 ()


  • Orthopaedic rod reducer
OBLIQUE EX02121226 14MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
EX02121226
In Commercial Distribution

  • 00643169165557 ()


  • Orthopaedic rod reducer
OBLIQUE EX02121225 12MM WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
EX02121225
In Commercial Distribution

  • 00643169165540 ()


  • Orthopaedic rod reducer
REAMER EX0112079 13MM DIAMETER BONE
MEDTRONIC SOFAMOR DANEK, INC.
EX0112079
In Commercial Distribution

  • 00643169164161 ()


  • Orthopaedic broach
HOLDER EX0312014 PIN
MEDTRONIC SOFAMOR DANEK, INC.
EX0312014
In Commercial Distribution

  • 00643169164154 ()


  • Surgical implant/trial-implant/sizer holder, reusable
FORCEPS EX0312095 BAYONETED ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0312095
In Commercial Distribution

  • 00643169164147 ()


  • Bone distraction forceps
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