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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SHAVER EX0111019 ROTATING
MEDTRONIC SOFAMOR DANEK, INC.
EX0111019
In Commercial Distribution

  • 00613994944863 ()


  • Bone file/rasp, manual, reusable
TAP EX0111148 3.0MM SMALL ID
MEDTRONIC SOFAMOR DANEK, INC.
EX0111148
In Commercial Distribution

  • 00613994944825 ()


  • Bone tap, reusable
TAP EX0111154 4.5-5.5MM, SELF DRILLING
MEDTRONIC SOFAMOR DANEK, INC.
EX0111154
In Commercial Distribution

  • 00613994944818 ()


  • Surgical drill guide, reusable
TRAY 7757225 VERTEX SEL INSTRUMENT 4OF 4
MEDTRONIC SOFAMOR DANEK, INC.
7757225
In Commercial Distribution

  • 00613994990921 ()


  • Instrument tray, reusable
TRAY 7757224 VERTEX SEL INSTRUMENT 3OF 4
MEDTRONIC SOFAMOR DANEK, INC.
7757224
In Commercial Distribution

  • 00613994990914 ()


  • Instrument tray, reusable
TRAY 7757223 VERTEX SEL INSTRUMENT 1OF 4
MEDTRONIC SOFAMOR DANEK, INC.
7757223
In Commercial Distribution

  • 00613994990907 ()


  • Instrument tray, reusable
TRAY 7757259 VERTEX SEL INSTRUMENT 2OF 4
MEDTRONIC SOFAMOR DANEK, INC.
7757259
In Commercial Distribution

  • 00613994990891 ()


  • Instrument tray, reusable
HELICOPTER REMOVAL TOOL EX0411005 6.35
MEDTRONIC SOFAMOR DANEK, INC.
EX0411005
In Commercial Distribution

  • 00613994990792 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER X0411043 SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X0411043
In Commercial Distribution

  • 00613994990778 ()


  • Orthopaedic implant driver
DRIVER EX0411014 LONG CANN PEEK
MEDTRONIC SOFAMOR DANEK, INC.
EX0411014
In Commercial Distribution

  • 00613994990761 ()


  • Surgical drill guide, reusable
CHANNEL EX0311445 16MM SI WORKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0311445
In Commercial Distribution

  • 00613994990754 ()


  • Orthopaedic rod reducer
CHANNEL EX0311444 14MM SI WORKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0311444
In Commercial Distribution

  • 00613994990747 ()


  • Orthopaedic rod reducer
POSTERIOR POSITIONER EX0411009 4.75
MEDTRONIC SOFAMOR DANEK, INC.
EX0411009
In Commercial Distribution

  • 00613994990723 ()


  • Orthopaedic fixation implant alignment tool
TAP X0411001 2.75
MEDTRONIC SOFAMOR DANEK, INC.
X0411001
In Commercial Distribution

  • 00613994988713 ()


  • Bone tap, reusable
TAP EX0311246 4.0MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0311246
In Commercial Distribution

  • 00613994986979 ()


  • Bone tap, reusable
TAP EX0311240 3.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0311240
In Commercial Distribution

  • 00613994986962 ()


  • Bone tap, reusable
REAMER EX0411015 CURVED LARGE
MEDTRONIC SOFAMOR DANEK, INC.
EX0411015
In Commercial Distribution

  • 00613994986726 ()


  • Orthopaedic broach
PROBE X0211245 THICK
MEDTRONIC SOFAMOR DANEK, INC.
X0211245
In Commercial Distribution

  • 00613994986696 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
SPREADER EX0411034 LAMINAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0411034
In Commercial Distribution

  • 00613994986337 ()


  • Bone distraction forceps
TORQUE EX0311188 4.75 COUNTER, HDLE ROTD
MEDTRONIC SOFAMOR DANEK, INC.
EX0311188
In Commercial Distribution

  • 00613994985415 ()


  • Orthopaedic counter-torque/rod-pushing instrument
TRAY X0411004 SPECIALS, 15 COMPART
MEDTRONIC SOFAMOR DANEK, INC.
X0411004
In Commercial Distribution

  • 00613994984081 ()


  • Instrument tray, reusable
SUITCASE X0311398 LEGACY 6.35 HA
MEDTRONIC SOFAMOR DANEK, INC.
X0311398
In Commercial Distribution

  • 00613994983046 ()


  • Instrument tray, reusable
RETRACTOR EX0311428 WEITLANER W/SPLINES
MEDTRONIC SOFAMOR DANEK, INC.
EX0311428
In Commercial Distribution

  • 00613994983039 ()


  • Surgical retractor/retraction system blade, reusable
PROBE EX0311430 THORACIC
MEDTRONIC SOFAMOR DANEK, INC.
EX0311430
In Commercial Distribution

  • 00613994983022 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE EX0311429 THORACIC
MEDTRONIC SOFAMOR DANEK, INC.
EX0311429
In Commercial Distribution

  • 00613994983015 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
DRILL X091005317 BIT
MEDTRONIC SOFAMOR DANEK, INC.
X091005317
In Commercial Distribution

  • 00613994982643 ()


  • Fluted surgical drill bit, reusable
DRILL X091005315 BIT
MEDTRONIC SOFAMOR DANEK, INC.
X091005315
In Commercial Distribution

  • 00613994982636 ()


  • Fluted surgical drill bit, reusable
DRILL X091005313 BIT
MEDTRONIC SOFAMOR DANEK, INC.
X091005313
In Commercial Distribution

  • 00613994982629 ()


  • Fluted surgical drill bit, reusable
DRILL X091005311 BIT
MEDTRONIC SOFAMOR DANEK, INC.
X091005311
In Commercial Distribution

  • 00613994982612 ()


  • Fluted surgical drill bit, reusable
AWL EX1010054 SQUARE LARGE
MEDTRONIC SOFAMOR DANEK, INC.
EX1010054
In Commercial Distribution

  • 00613994929303 ()


  • Bone awl, reusable
AWL EX1010053 SQUARE SMALL
MEDTRONIC SOFAMOR DANEK, INC.
EX1010053
In Commercial Distribution

  • 00613994929297 ()


  • Bone awl, reusable
DILATOR/RASP EX1210015 13MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210015
In Commercial Distribution

  • 00613994927248 ()


  • Laparoscopic access cannula dilator
DILATOR/RASP EX1210014 11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210014
In Commercial Distribution

  • 00613994927231 ()


  • Bone file/rasp, manual, reusable
DILATOR/RASP EX1210013 9MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210013
In Commercial Distribution

  • 00613994927224 ()


  • Bone file/rasp, manual, reusable
PENFIELD EX1210208 SINGLE ENDED
MEDTRONIC SOFAMOR DANEK, INC.
EX1210208
In Commercial Distribution

  • 00613994926364 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
AWL EX1210182 11MM W/SHORT SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210182
In Commercial Distribution

  • 00613994925916 ()


  • Bone awl, reusable
MEDIAL LATERAL BLADE EX1210203 10CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210203
In Commercial Distribution

  • 00613994925848 ()


  • Orthopaedic knife
MEDIAL LATERAL BLADE EX1210202 8CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210202
In Commercial Distribution

  • 00613994925831 ()


  • Orthopaedic knife
MEDIAL LATERAL BLADE EX1210201 6CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210201
In Commercial Distribution

  • 00613994925824 ()


  • Orthopaedic knife
MEDIAL LATERAL BLADE EX1210200 4CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210200
In Commercial Distribution

  • 00613994925817 ()


  • Orthopaedic knife
TAMP EX1110240 BONE FUNNEL
MEDTRONIC SOFAMOR DANEK, INC.
EX1110240
Not in Commercial Distribution

  • 00613994923684 ()


  • Surgical tamp, reusable
BONE FUNNEL EX1110156 12 MM BEVELED
MEDTRONIC SOFAMOR DANEK, INC.
EX1110156
In Commercial Distribution

  • 00613994923677 ()


  • Bone graft funnel
OSTEOTOME EX1210161 4MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210161
In Commercial Distribution

  • 00613994923660 ()


  • Orthopaedic osteotome
DRIVER EX1210155 GENERAL SS MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX1210155
In Commercial Distribution

  • 00613994923653 ()


  • Orthopaedic implant driver
GUIDE EX1110199 DOUBLE BARREL DTS INF
MEDTRONIC SOFAMOR DANEK, INC.
EX1110199
In Commercial Distribution

  • 00613994923646 ()


  • General internal orthopaedic fixation system implantation kit
GUIDE EX1110198 DOUBLE BARREL DTS MID
MEDTRONIC SOFAMOR DANEK, INC.
EX1110198
In Commercial Distribution

  • 00613994923639 ()


  • General internal orthopaedic fixation system implantation kit
HANDLE EX1210146 DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX1210146
In Commercial Distribution

  • 00613994923622 ()


  • Orthopaedic surgical distractor, internal
HANDLE EX1210145 DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX1210145
In Commercial Distribution

  • 00613994923615 ()


  • Orthopaedic surgical distractor, internal
HANDLE EX1210144 DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX1210144
In Commercial Distribution

  • 00613994923608 ()


  • Orthopaedic surgical distractor, internal
COBB EX1210165 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210165
In Commercial Distribution

  • 00613994923592 ()


  • Bone lever/elevator, reusable
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