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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DRILL GUIDE EX0912015 VARIABLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0912015
In Commercial Distribution

  • 00643169271548 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX0912014 FIXED
MEDTRONIC SOFAMOR DANEK, INC.
EX0912014
In Commercial Distribution

  • 00643169271531 ()


  • Surgical drill guide, reusable
ADAPTOR EX0712206 QC TO TRI-FLAT
MEDTRONIC SOFAMOR DANEK, INC.
EX0712206
In Commercial Distribution

  • 00643169269743 ()


  • Surgical screwdriver, reusable
BONE FUNNEL TAMP EX0912055 WITH CONE TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0912055
In Commercial Distribution

  • 00643169266513 ()


  • Surgical tamp, reusable
DRIVER EX0912066 BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0912066
In Commercial Distribution

  • 00643169266506 ()


  • Orthopaedic implant driver
4.75 HANDLE EX0912003 90 DEG WELD
MEDTRONIC SOFAMOR DANEK, INC.
EX0912003
In Commercial Distribution

  • 00643169263024 ()


  • Orthopaedic counter-torque/rod-pushing instrument
MICROPITUITARY X1110216 2MM NEEDLE HOLD
MEDTRONIC SOFAMOR DANEK, INC.
X1110216
In Commercial Distribution

  • 00643169263017 ()


  • Orthopaedic joint/limb rongeur
AWL EX0812026 BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0812026
In Commercial Distribution

  • 00643169249813 ()


  • Bone awl, reusable
CURETTE EX0812029 7.5MM RING
MEDTRONIC SOFAMOR DANEK, INC.
EX0812029
In Commercial Distribution

  • 00643169249806 ()


  • Bone curette, reusable
CURETTE EX0812028 8MM RING RIGHT HANDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0812028
In Commercial Distribution

  • 00643169249790 ()


  • Bone curette, reusable
CURETTE EX0812027 8MM RING LEFT HANDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0812027
In Commercial Distribution

  • 00643169249783 ()


  • Bone curette, reusable
TAMP EX0812963 CURVED
MEDTRONIC SOFAMOR DANEK, INC.
EX0812963
In Commercial Distribution

  • 00643169249776 ()


  • Surgical tamp, reusable
TAP EX06124024 DIA 7.0 REDUCED THREAD
MEDTRONIC SOFAMOR DANEK, INC.
EX06124024
In Commercial Distribution

  • 00643169247352 ()


  • Bone tap, reusable
TAP EX06124023 DIA 6.0 REDUCED THREAD
MEDTRONIC SOFAMOR DANEK, INC.
EX06124023
In Commercial Distribution

  • 00643169247345 ()


  • Bone tap, reusable
TAP EX06124022 DIA 5.0 REDUCED THREAD
MEDTRONIC SOFAMOR DANEK, INC.
EX06124022
In Commercial Distribution

  • 00643169247338 ()


  • Bone tap, reusable
TAP EX06124021 DIA 4.0 REDUCED THREAD
MEDTRONIC SOFAMOR DANEK, INC.
EX06124021
In Commercial Distribution

  • 00643169247321 ()


  • Bone tap, reusable
TAP EX06124020 DIA 3.25 REDUCED THREAD
MEDTRONIC SOFAMOR DANEK, INC.
EX06124020
In Commercial Distribution

  • 00643169247314 ()


  • Bone tap, reusable
DRILL STOP 8761000 CERVICAL ADJUSTABLE
MEDTRONIC SOFAMOR DANEK, INC.
8761000
In Commercial Distribution

  • 00643169247123 ()


  • Fluted surgical drill bit, reusable
GUIDE TRIAL EX06124064 10MM X 27.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124064
In Commercial Distribution

  • 00643169247062 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124063 10MM X 25MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124063
In Commercial Distribution

  • 00643169247055 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124062 9MM X 27.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124062
In Commercial Distribution

  • 00643169247048 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124061 9MM X 25MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124061
In Commercial Distribution

  • 00643169247031 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124060 8MM X 25MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124060
In Commercial Distribution

  • 00643169247024 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124059 8MM X 23MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124059
In Commercial Distribution

  • 00643169247017 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124058 7MM X 25MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124058
In Commercial Distribution

  • 00643169247000 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124057 7MM X 23MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124057
In Commercial Distribution

  • 00643169246997 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124056 6MM X 23MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124056
In Commercial Distribution

  • 00643169246980 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124055 6MM X 21MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124055
In Commercial Distribution

  • 00643169246973 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124054 5MM X 23MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124054
In Commercial Distribution

  • 00643169246966 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124053 5MM X 21MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124053
In Commercial Distribution

  • 00643169246959 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124052 4MM X 21MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124052
In Commercial Distribution

  • 00643169246942 ()


  • Surgical drill guide, reusable
GUIDE TRIAL EX06124051 4MM X 19MM
MEDTRONIC SOFAMOR DANEK, INC.
EX06124051
In Commercial Distribution

  • 00643169246935 ()


  • Surgical drill guide, reusable
TAP EX0712095 DIA. 8.5 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0712095
In Commercial Distribution

  • 00643169246812 ()


  • Bone tap, reusable
TAP EX0712094 DIA. 7.0 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0712094
In Commercial Distribution

  • 00643169246805 ()


  • Bone tap, reusable
TAP EX0712093 DIA. 6.5 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0712093
In Commercial Distribution

  • 00643169246799 ()


  • Bone tap, reusable
RETRACTOR 2670006 WAVE RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
2670006
In Commercial Distribution

  • 00643169245327 ()


  • Surgical retractor/retraction system blade, reusable
ROD 2670009 WAVE POSITIONING ROD
MEDTRONIC SOFAMOR DANEK, INC.
2670009
In Commercial Distribution

  • 00643169245068 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
BIT X0812959 11MM SHORT DEPTH DRILL
MEDTRONIC SOFAMOR DANEK, INC.
X0812959
In Commercial Distribution

  • 00643169245037 ()


  • Fluted surgical drill bit, reusable
BONE REAMER EX0712186 LEGACY
MEDTRONIC SOFAMOR DANEK, INC.
EX0712186
In Commercial Distribution

  • 00643169244436 ()


  • Orthopaedic broach
HOOK EX0712119 ANGLED NERVE
MEDTRONIC SOFAMOR DANEK, INC.
EX0712119
In Commercial Distribution

  • 00643169244078 ()


  • General internal orthopaedic fixation system implantation kit
TRANSLATOR EX1011022 HINGED FOR 6.35
MEDTRONIC SOFAMOR DANEK, INC.
EX1011022
In Commercial Distribution

  • 00643169097995 ()


  • Orthopaedic fixation implant alignment tool
TRANSLATOR EX1011021 HINGED FOR 5.5
MEDTRONIC SOFAMOR DANEK, INC.
EX1011021
In Commercial Distribution

  • 00643169097988 ()


  • Orthopaedic fixation implant alignment tool
HANDLE EX1011061 FLEX AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX1011061
In Commercial Distribution

  • 00643169097964 ()


  • Surgical instrument handle, non-torque-limiting
AWL EX1011060 FLEXIBLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1011060
In Commercial Distribution

  • 00643169097957 ()


  • Bone awl, reusable
TUBE EX1011059 FLEXIBLE GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
EX1011059
In Commercial Distribution

  • 00643169097940 ()


  • General internal orthopaedic fixation system implantation kit
BONE BIOPSY DEVICE F05A BBD SIZE 3
MEDTRONIC SOFAMOR DANEK, INC.
F05A
In Commercial Distribution

  • 00643169097063 ()


  • Bone access cannula
TAP EX1011165 7.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011165
In Commercial Distribution

  • 00643169096417 ()


  • Bone tap, reusable
TAP EX1011164 7.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011164
In Commercial Distribution

  • 00643169096400 ()


  • Bone tap, reusable
TAP EX1011163 6.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011163
In Commercial Distribution

  • 00643169096394 ()


  • Bone tap, reusable
TAP EX1011162 6.0MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1011162
In Commercial Distribution

  • 00643169096387 ()


  • Bone tap, reusable
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