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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TEMPLATE EX1210009 9MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210009
In Commercial Distribution

  • 00613994920126 ()


  • Surgical implant template, reusable
TEMPLATE EX1210008 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210008
In Commercial Distribution

  • 00613994920119 ()


  • Surgical implant template, reusable
TEMPLATE EX1210007 7MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210007
In Commercial Distribution

  • 00613994920102 ()


  • Surgical implant template, reusable
TEMPLATE EX1210006 6MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210006
In Commercial Distribution

  • 00613994920096 ()


  • Surgical implant template, reusable
TEMPLATE EX1210005 5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1210005
In Commercial Distribution

  • 00613994920089 ()


  • Surgical implant template, reusable
TAP EX1110186 3.0MM SMALL TIP DIAMETER
MEDTRONIC SOFAMOR DANEK, INC.
EX1110186
In Commercial Distribution

  • 00613994920027 ()


  • Bone tap, reusable
LEFT X1110171 SLEEVED IN-SITU BENDER
MEDTRONIC SOFAMOR DANEK, INC.
X1110171
In Commercial Distribution

  • 00613994920010 ()


  • Manual orthopaedic bender, reusable
RIGHT X1110170 SLEEVED IN-SITU BENDER
MEDTRONIC SOFAMOR DANEK, INC.
X1110170
In Commercial Distribution

  • 00613994920003 ()


  • Manual orthopaedic bender, reusable
RIGHT X1110169 SLEEVED CORONAL BENDER
MEDTRONIC SOFAMOR DANEK, INC.
X1110169
In Commercial Distribution

  • 00613994919991 ()


  • Manual orthopaedic bender, reusable
LEFT X1110168 SLEEVED CORONAL BENDER
MEDTRONIC SOFAMOR DANEK, INC.
X1110168
In Commercial Distribution

  • 00613994919984 ()


  • Manual orthopaedic bender, reusable
EXTENDER EX1110226 SCREW T25 196MM LGTH
MEDTRONIC SOFAMOR DANEK, INC.
EX1110226
In Commercial Distribution

  • 00613994919977 ()


  • General internal orthopaedic fixation system implantation kit
HANDLE EX1110067 UNIV CANNUL THREADED
MEDTRONIC SOFAMOR DANEK, INC.
EX1110067
In Commercial Distribution

  • 00613994919960 ()


  • Surgical instrument handle, non-torque-limiting
OBTURATOR EX1110039 THREADED T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1110039
In Commercial Distribution

  • 00613994919953 ()


  • Surgical instrument handle, non-torque-limiting
PROBE EX1010851 CANNUL STRGHT BALL HDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1010851
In Commercial Distribution

  • 00613994919946 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
GUIDE EX1110219 DTS
MEDTRONIC SOFAMOR DANEK, INC.
EX1110219
In Commercial Distribution

  • 00613994919052 ()


  • General internal orthopaedic fixation system implantation kit
AWL EX1110149 4.5X40 METAL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1110149
In Commercial Distribution

  • 00613994919007 ()


  • Bone awl, reusable
RETRACTOR X1110217 25MMX11CM EXPANDING
MEDTRONIC SOFAMOR DANEK, INC.
X1110217
In Commercial Distribution

  • 00613994918994 ()


  • Surgical retractor/retraction system blade, reusable
MARKER EX1110163 PEDICLE, HAND HELD
MEDTRONIC SOFAMOR DANEK, INC.
EX1110163
In Commercial Distribution

  • 00613994918987 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
SHIM EX1110222 GUIDE, L=250MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1110222
In Commercial Distribution

  • 00613994918970 ()


  • Surgical retraction system, reusable
MICROPITUITARY EX1110216 NEEDLE HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
EX1110216
In Commercial Distribution

  • 00613994918963 ()


  • Orthopaedic joint/limb rongeur
PLUNGER EX1010068 DELIVERY SYSTEM
MEDTRONIC SOFAMOR DANEK, INC.
EX1010068
In Commercial Distribution

  • 00613994918956 ()


  • Bone graft funnel
BARREL EX1010066 DELIVERY SYSTEM 5CC
MEDTRONIC SOFAMOR DANEK, INC.
EX1010066
In Commercial Distribution

  • 00613994918932 ()


  • Orthopaedic surgical distractor, internal
SCREWDRIVER EX1110162 FIXED SLEEVE 5.5
MEDTRONIC SOFAMOR DANEK, INC.
EX1110162
In Commercial Distribution

  • 00613994918918 ()


  • Orthopaedic implant driver
DRIVER EX1110243 EXTENDER
MEDTRONIC SOFAMOR DANEK, INC.
EX1110243
In Commercial Distribution

  • 00613994918482 ()


  • Orthopaedic implant driver
GUIDE EX1210019 SNG BRL DTS GUIDE SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210019
In Commercial Distribution

  • 00613994918475 ()


  • General internal orthopaedic fixation system implantation kit
HOLDER EX1210048 GENERAL SS DILATOR
MEDTRONIC SOFAMOR DANEK, INC.
EX1210048
In Commercial Distribution

  • 00613994918468 ()


  • Laparoscopic access cannula dilator
DRIVER EX1110238 2.5 MM FLEX SCREWSHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX1110238
In Commercial Distribution

  • 00613994917966 ()


  • Orthopaedic implant driver
ROTATE CUTTER EX1110228 SMALL 5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1110228
In Commercial Distribution

  • 00613994917935 ()


  • Orthopaedic knife
ADJUSTER EX0610140 ROD POSITION
MEDTRONIC SOFAMOR DANEK, INC.
EX0610140
In Commercial Distribution

  • 00613994917522 ()


  • Orthopaedic fixation implant alignment tool
GRASPER EX1110003 PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1110003
In Commercial Distribution

  • 00613994915726 ()


  • Bone file/rasp, manual, reusable
PROBE EX1010187 FEELER 2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1010187
In Commercial Distribution

  • 00613994915719 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
DRIVER X1110185 PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X1110185
In Commercial Distribution

  • 00613994915696 ()


  • Orthopaedic implant driver
HANDLE EX1010928 ASSEMBLY
MEDTRONIC SOFAMOR DANEK, INC.
EX1010928
In Commercial Distribution

  • 00613994913623 ()


  • Surgical instrument handle, non-torque-limiting
PUSHER X1110159 DILATOR, T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1110159
In Commercial Distribution

  • 00613994913616 ()


  • Laparoscopic access cannula dilator
NERVE ROOT RETRACTOR EX0410043 12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0410043
In Commercial Distribution

  • 00613994913586 ()


  • Surgical retractor/retraction system blade, reusable
NERVE ROOT RETRACTOR EX0410042 9MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0410042
In Commercial Distribution

  • 00613994913579 ()


  • Surgical retractor/retraction system blade, reusable
NERVE ROOT RETRACTOR EX0410041 6MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0410041
In Commercial Distribution

  • 00613994913562 ()


  • Surgical retractor/retraction system blade, reusable
TAP EX1110152 3.5 MM SHAFT TAPERED
MEDTRONIC SOFAMOR DANEK, INC.
EX1110152
In Commercial Distribution

  • 00613994910653 ()


  • Bone tap, reusable
ROD REDUCER X1110110 LATERAL
MEDTRONIC SOFAMOR DANEK, INC.
X1110110
In Commercial Distribution

  • 00613994910493 ()


  • Orthopaedic rod reducer
LH DISTRACTOR EX1110187 5.5 TLIF/PLIF
MEDTRONIC SOFAMOR DANEK, INC.
EX1110187
In Commercial Distribution

  • 00613994910479 ()


  • Orthopaedic surgical distractor, internal
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