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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RETRACTOR EX0512306 BLADE 6CM
MEDTRONIC SOFAMOR DANEK, INC.
EX0512306
In Commercial Distribution

  • 00643169190061 ()


  • Surgical retraction system, reusable
COMPRESSOR EX0412251 PARALLEL COMPRESSOR
MEDTRONIC SOFAMOR DANEK, INC.
EX0412251
In Commercial Distribution

  • 00643169189232 ()


  • Orthopaedic surgical distractor, internal
PIN EX0412193 STABILITY - 23CM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412193
In Commercial Distribution

  • 00643169189126 ()


  • General internal orthopaedic fixation system implantation kit
CURETTE EX0512024 RAKE REV ANG
MEDTRONIC SOFAMOR DANEK, INC.
EX0512024
In Commercial Distribution

  • 00643169188396 ()


  • Bone curette, reusable
PROBE X0512332 ROTATED BAYONETTED
MEDTRONIC SOFAMOR DANEK, INC.
X0512332
In Commercial Distribution

  • 00643169188389 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
AWL X0812310 SILICONE HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0812310
In Commercial Distribution

  • 00643169233935 ()


  • Bone awl, reusable
GRIPPER X0712187 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
X0712187
In Commercial Distribution

  • 00643169233928 ()


  • Surgical flat-nosed pliers
BLADE X0512250 10CM NARROW ALUMINUM
MEDTRONIC SOFAMOR DANEK, INC.
X0512250
In Commercial Distribution

  • 00643169231764 ()


  • Orthopaedic knife
BLADE X0512249 9CM NARROW ALUMINUM
MEDTRONIC SOFAMOR DANEK, INC.
X0512249
In Commercial Distribution

  • 00643169231757 ()


  • Orthopaedic knife
BLADE X0512248 8CM NARROW ALUMINUM
MEDTRONIC SOFAMOR DANEK, INC.
X0512248
In Commercial Distribution

  • 00643169231740 ()


  • Orthopaedic knife
BLADE X0512246 6CM NARROW ALUMINUM
MEDTRONIC SOFAMOR DANEK, INC.
X0512246
In Commercial Distribution

  • 00643169231726 ()


  • Orthopaedic knife
BLADE X0512245 5CM NARROW ALUMINUM
MEDTRONIC SOFAMOR DANEK, INC.
X0512245
In Commercial Distribution

  • 00643169231719 ()


  • Orthopaedic knife
DRIVER EX0712211 SHORT T27 QC
MEDTRONIC SOFAMOR DANEK, INC.
EX0712211
In Commercial Distribution

  • 00643169231702 ()


  • Orthopaedic implant driver
TAP EX0712199 GENERAL SS 12.5
MEDTRONIC SOFAMOR DANEK, INC.
EX0712199
In Commercial Distribution

  • 00643169230750 ()


  • Bone tap, reusable
TAP EX0712198 GENERAL SS 11.5
MEDTRONIC SOFAMOR DANEK, INC.
EX0712198
In Commercial Distribution

  • 00643169230743 ()


  • Bone tap, reusable
GUIDE EX06123867 ADJUSTABLE DEPTH DRILL
MEDTRONIC SOFAMOR DANEK, INC.
EX06123867
In Commercial Distribution

  • 00643169230705 ()


  • Surgical drill guide, reusable
COUNTER TORQUE X0812017 HEAD MANIPULATOR
MEDTRONIC SOFAMOR DANEK, INC.
X0812017
In Commercial Distribution

  • 00643169228283 ()


  • Surgical instrument handle, non-torque-limiting
DRIVER EX0512317 5.5 MAS BAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0512317
In Commercial Distribution

  • 00643169195202 ()


  • Orthopaedic implant driver
DRIVER EX0512316 5.5 MAS STEPPED
MEDTRONIC SOFAMOR DANEK, INC.
EX0512316
In Commercial Distribution

  • 00643169195196 ()


  • Orthopaedic implant driver
DRIVER EX0512314 4.75 MAS STEPPED
MEDTRONIC SOFAMOR DANEK, INC.
EX0512314
In Commercial Distribution

  • 00643169195172 ()


  • Orthopaedic implant driver
REMOVER EX1111157 6.35MM SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX1111157
In Commercial Distribution

  • 00643169194885 ()


  • Orthopaedic implantation sleeve, reusable
TAP EX06123141 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06123141
In Commercial Distribution

  • 00643169194656 ()


  • Bone tap, reusable
RETRACTOR EX06123170 NERVE ROOT
MEDTRONIC SOFAMOR DANEK, INC.
EX06123170
In Commercial Distribution

  • 00643169194557 ()


  • Surgical retractor/retraction system blade, reusable
HAMMER 2670013 SLAP HAMMER
MEDTRONIC SOFAMOR DANEK, INC.
2670013
In Commercial Distribution

  • 00643169241862 ()


  • Orthopaedic implantation hammering attachment
5.5 STRAIGHT EX0213028 IMPLANT HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
EX0213028
In Commercial Distribution

  • 00643169319622 ()


  • Surgical implant/trial-implant/sizer holder, reusable
DILATOR EX1112025 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1112025
In Commercial Distribution

  • 00643169318861 ()


  • Laparoscopic access cannula dilator
DILATOR EX1112024 CORE
MEDTRONIC SOFAMOR DANEK, INC.
EX1112024
In Commercial Distribution

  • 00643169318854 ()


  • Laparoscopic access cannula dilator
DILATOR EX1112023 HANDGRIP
MEDTRONIC SOFAMOR DANEK, INC.
EX1112023
In Commercial Distribution

  • 00643169318847 ()


  • Laparoscopic access cannula dilator
DTS GUIDE EX1112003 VAR. SINGLE BARREL
MEDTRONIC SOFAMOR DANEK, INC.
EX1112003
In Commercial Distribution

  • 00643169316737 ()


  • General internal orthopaedic fixation system implantation kit
TAMP EX1212053 CURVED 14MM X 6MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1212053
In Commercial Distribution

  • 00643169315853 ()


  • Surgical tamp, reusable
STRAIGHT EX0113035 IMPLANT HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
EX0113035
In Commercial Distribution

  • 00643169315846 ()


  • Surgical implant/trial-implant/sizer holder, reusable
DILATOR X1012401 24.8MM X 200MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012401
In Commercial Distribution

  • 00643169315686 ()


  • Laparoscopic access cannula dilator
RASP EX0113020 BAYONETTED
MEDTRONIC SOFAMOR DANEK, INC.
EX0113020
In Commercial Distribution

  • 00643169313484 ()


  • Bone file/rasp, manual, reusable
DISTRACTOR EX0113019 10MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0113019
In Commercial Distribution

  • 00643169313477 ()


  • Orthopaedic surgical distractor, internal
RASP EX0113018 9MM X 13MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0113018
In Commercial Distribution

  • 00643169313460 ()


  • Bone file/rasp, manual, reusable
RASP EX0113017 8MM X 12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0113017
In Commercial Distribution

  • 00643169313453 ()


  • Bone file/rasp, manual, reusable
RASP EX0113016 7MM X 11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0113016
In Commercial Distribution

  • 00643169313446 ()


  • Bone file/rasp, manual, reusable
IMPACTOR EX0113015 TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0113015
In Commercial Distribution

  • 00643169313439 ()


  • Orthopaedic implant impactor, reusable
RETRACTOR EX0113014 SQ TUBULAR 10X14
MEDTRONIC SOFAMOR DANEK, INC.
EX0113014
In Commercial Distribution

  • 00643169313422 ()


  • Surgical retractor/retraction system blade, reusable
DRILL BIT EX0113013 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0113013
In Commercial Distribution

  • 00643169313415 ()


  • Fluted surgical drill bit, reusable
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