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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KERRISON EX0111017 40 UP 4MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0111017
In Commercial Distribution

  • 00613994932587 ()


  • Bone curette, reusable
KERRISON EX0111016 40 UP 2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0111016
In Commercial Distribution

  • 00613994932570 ()


  • Bone curette, reusable
DRIVER EX0111009 SS THREADED SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0111009
In Commercial Distribution

  • 00613994932563 ()


  • Orthopaedic implant driver
RIGHT ANGLED CURETTE EX0111102 REDUCED
MEDTRONIC SOFAMOR DANEK, INC.
EX0111102
In Commercial Distribution

  • 00613994932556 ()


  • Bone curette, reusable
LEFT ANGLED CURETTE EX0111101 REDUCED
MEDTRONIC SOFAMOR DANEK, INC.
EX0111101
In Commercial Distribution

  • 00613994932549 ()


  • Bone curette, reusable
BREAK-OFF DRIVER EX1210175 T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1210175
In Commercial Distribution

  • 00613994931559 ()


  • Surgical drill guide, reusable
6.35 INSITU BENDER EX1210213 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210213
In Commercial Distribution

  • 00613994931542 ()


  • Manual orthopaedic bender, reusable
6.35 INSITU BENDER EX1210212 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210212
In Commercial Distribution

  • 00613994931535 ()


  • Manual orthopaedic bender, reusable
DISTRACTOR EX1210187 SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX1210187
In Commercial Distribution

  • 00613994930378 ()


  • Orthopaedic surgical distractor, internal
REAMER EX0111015 PEDCL PRBE 6.5 AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX0111015
In Commercial Distribution

  • 00613994930354 ()


  • Orthopaedic broach
REAMER EX0111014 PEDCL PRBE 5.5 AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX0111014
In Commercial Distribution

  • 00613994930347 ()


  • Orthopaedic broach
REAMER EX0111013 PEDCL PRBE 4.5 AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX0111013
In Commercial Distribution

  • 00613994930330 ()


  • Orthopaedic broach
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
IMPACTOR EX0211203 GRAFT STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0211203
In Commercial Distribution

  • 00613994953049 ()


  • General internal orthopaedic fixation system implantation kit
OSTEOTOME EX0211202 8MM STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0211202
In Commercial Distribution

  • 00613994953032 ()


  • Orthopaedic osteotome
SLEEVE EX0211217 6.35 REMOVAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0211217
In Commercial Distribution

  • 00613994953025 ()


  • Orthopaedic implantation sleeve, reusable
PROBE EX0211215 BALL HANDLE THORACIC
MEDTRONIC SOFAMOR DANEK, INC.
EX0211215
In Commercial Distribution

  • 00613994953018 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
HANDLE EX0211178 BROACH
MEDTRONIC SOFAMOR DANEK, INC.
EX0211178
In Commercial Distribution

  • 00613994953001 ()


  • Orthopaedic broach
RETRACTOR EX0111106 MEDIUM
MEDTRONIC SOFAMOR DANEK, INC.
EX0111106
In Commercial Distribution

  • 00613994952141 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0111105 SMALL
MEDTRONIC SOFAMOR DANEK, INC.
EX0111105
In Commercial Distribution

  • 00613994952134 ()


  • Surgical retractor/retraction system blade, reusable
SCREWDRIVER EX0211188 T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0211188
In Commercial Distribution

  • 00613994952103 ()


  • Orthopaedic implant driver
HOLDER EX0211209 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0211209
In Commercial Distribution

  • 00613994952097 ()


  • Surgical implant/trial-implant/sizer holder, reusable
SLAP HAMMER EX0111096 K-WIRE
MEDTRONIC SOFAMOR DANEK, INC.
EX0111096
In Commercial Distribution

  • 00613994951250 ()


  • Orthopaedic implantation hammering attachment
SCRAPER EX1210156 PUSH
MEDTRONIC SOFAMOR DANEK, INC.
EX1210156
In Commercial Distribution

  • 00613994951243 ()


  • Orthopaedic knife
CURETTE EX1210207 RIGHT ANGLED CUP
MEDTRONIC SOFAMOR DANEK, INC.
EX1210207
In Commercial Distribution

  • 00613994951236 ()


  • Bone curette, reusable
CURETTE EX1210206 LEFT ANGLED CUP
MEDTRONIC SOFAMOR DANEK, INC.
EX1210206
In Commercial Distribution

  • 00613994951229 ()


  • Bone curette, reusable
CURETTE EX1210205 STRAIGHT CUP
MEDTRONIC SOFAMOR DANEK, INC.
EX1210205
In Commercial Distribution

  • 00613994951212 ()


  • Bone curette, reusable
CUP CURETTE EX0211192 LEFT ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0211192
In Commercial Distribution

  • 00613994951205 ()


  • Bone curette, reusable
CUP CURETTE EX0211191 RIGHT ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0211191
In Commercial Distribution

  • 00613994951199 ()


  • Bone curette, reusable
CUP CURETTE EX0211190 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0211190
In Commercial Distribution

  • 00613994951182 ()


  • Bone curette, reusable
TAP EX0111127 5.5 REDUCED DIAMETER
MEDTRONIC SOFAMOR DANEK, INC.
EX0111127
In Commercial Distribution

  • 00613994950048 ()


  • Bone tap, reusable
RASP EX1210210 RIGHT ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX1210210
In Commercial Distribution

  • 00613994949035 ()


  • Bone file/rasp, manual, reusable
DRIVER EX0111143 GENERAL SS 5.5 MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0111143
In Commercial Distribution

  • 00613994944832 ()


  • Orthopaedic implant driver
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
ELEVATOR EX0112101 COBB DOWN ANGLE 10MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112101
In Commercial Distribution

  • 00643169137431 ()


  • Bone lever/elevator, reusable
ELEVATOR EX0112100 COBB UP ANGLE 10MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112100
In Commercial Distribution

  • 00643169137424 ()


  • Bone lever/elevator, reusable
DRILL GUIDE EX0112172 40MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112172
In Commercial Distribution

  • 00643169133419 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX0112171 35MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112171
In Commercial Distribution

  • 00643169133402 ()


  • Surgical drill guide, reusable
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