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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TREPHINE X0416015 9.5MM BONE SCREW
MEDTRONIC SOFAMOR DANEK, INC.
X0416015
In Commercial Distribution

  • 00643169776951 ()


  • Bone trephine, reusable
TREPHINE X0416014 8.5MM BONE SCREW
MEDTRONIC SOFAMOR DANEK, INC.
X0416014
In Commercial Distribution

  • 00643169776944 ()


  • Bone trephine, reusable
SCREWDRIVER EX1216010 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1216010
In Commercial Distribution

  • 00643169957251 ()


  • General internal orthopaedic fixation system implantation kit
OBTURATOR EX0117044
MEDTRONIC SOFAMOR DANEK, INC.
EX0117044
In Commercial Distribution

  • 00643169956759 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE EX0117043 CANNULATED LUMBAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0117043
In Commercial Distribution

  • 00643169956742 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
ROD HOLDER EX0117004 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
EX0117004
In Commercial Distribution

  • 00643169954403 ()


  • Surgical implant/trial-implant/sizer holder, reusable
OBTURATOR EX0117018
MEDTRONIC SOFAMOR DANEK, INC.
EX0117018
In Commercial Distribution

  • 00643169953512 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
DRIVER EX1016091 MAS SHORT 4.75MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1016091
In Commercial Distribution

  • 00643169953086 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX1016090 MAS SHORT 5.5/6.0MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1016090
In Commercial Distribution

  • 00643169953079 ()


  • General internal orthopaedic fixation system implantation kit
INSTRUMENT EX1116116 SCREW REMOVAL T8T10
MEDTRONIC SOFAMOR DANEK, INC.
EX1116116
In Commercial Distribution

  • 00643169949997 ()


  • Surgical screwdriver, reusable
PROBE EX1116059 CANULATED LUER CONECTION
MEDTRONIC SOFAMOR DANEK, INC.
EX1116059
In Commercial Distribution

  • 00643169939844 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
COMPRESSOR EX1116115 MECHANICAL 4.75MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1116115
In Commercial Distribution

  • 00643169939837 ()


  • Orthopaedic surgical distractor, internal
RETRACTOR EX1116113 WDE SUCTON LNG TNGUE
MEDTRONIC SOFAMOR DANEK, INC.
EX1116113
In Commercial Distribution

  • 00643169939820 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
PUSHER EX1016025 4.5
MEDTRONIC SOFAMOR DANEK, INC.
EX1016025
In Commercial Distribution

  • 00643169939424 ()


  • Orthopaedic fixation implant alignment tool
DRIVER EX1116062 T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1116062
In Commercial Distribution

  • 00643169937987 ()


  • General internal orthopaedic fixation system implantation kit
COMPRSSOR/DISTRCTOR X1116110 VRTEBRL BDY
MEDTRONIC SOFAMOR DANEK, INC.
X1116110
In Commercial Distribution

  • 00643169936133 ()


  • Orthopaedic surgical distractor, internal
AWL EX1116023 9.6MM U-JOINT
MEDTRONIC SOFAMOR DANEK, INC.
EX1116023
In Commercial Distribution

  • 00643169931718 ()


  • Bone awl, reusable
DRIVER EX0616012 SHORTEN T8-T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0616012
In Commercial Distribution

  • 00643169800106 ()


  • Surgical screwdriver, reusable
FRENCH BENDER EX0516126 W/OFST SLC HNDLS
MEDTRONIC SOFAMOR DANEK, INC.
EX0516126
In Commercial Distribution

  • 00643169799943 ()


  • Manual orthopaedic bender, reusable
SCREWDRIVER EX0616055 FLEXIBLE T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0616055
In Commercial Distribution

  • 00643169799677 ()


  • Bone awl, reusable
AWL EX0616054 STRGHT FLEXIBLE-TROCAR TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0616054
In Commercial Distribution

  • 00643169799660 ()


  • Surgical screwdriver, reusable
BENDR X0616056 3 RLLR FRNCH WTH STP BTTN
MEDTRONIC SOFAMOR DANEK, INC.
X0616056
In Commercial Distribution

  • 00643169794726 ()


  • Manual orthopaedic bender, reusable
RASP X0715055 OVAL
MEDTRONIC SOFAMOR DANEK, INC.
X0715055
In Commercial Distribution

  • 00643169709652 ()


  • Bone file/rasp, manual, reusable
BENDING IRON EX0915054 STRAIGHT L
MEDTRONIC SOFAMOR DANEK, INC.
EX0915054
In Commercial Distribution

  • 00643169706002 ()


  • Manual orthopaedic bender, reusable
BENDING IRON EX0915053 STRAIGHT R
MEDTRONIC SOFAMOR DANEK, INC.
EX0915053
In Commercial Distribution

  • 00643169705999 ()


  • Manual orthopaedic bender, reusable
BENDING IRON EX0915051 ANGLED R
MEDTRONIC SOFAMOR DANEK, INC.
EX0915051
In Commercial Distribution

  • 00643169705975 ()


  • Manual orthopaedic bender, reusable
AWL EX1015048 BULLET NOSE
MEDTRONIC SOFAMOR DANEK, INC.
EX1015048
In Commercial Distribution

  • 00643169704824 ()


  • Orthopaedic knife
ELEVATOR EX0915075 FACET FREER
MEDTRONIC SOFAMOR DANEK, INC.
EX0915075
In Commercial Distribution

  • 00643169703896 ()


  • Bone lever/elevator, reusable
PROBE EX1115019 XXL STRAIGHT THORACIC
MEDTRONIC SOFAMOR DANEK, INC.
EX1115019
In Commercial Distribution

  • 00643169702752 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
DEROTATOR EX0915050 APICAL 5.5/6.0 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0915050
In Commercial Distribution

  • 00643169702745 ()


  • Orthopaedic counter-torque/rod-pushing instrument
ELEVATOR X1015002 RIGHT OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X1015002
In Commercial Distribution

  • 00643169699878 ()


  • Bone lever/elevator, reusable
ELEVATOR X1015001 LEFT OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X1015001
In Commercial Distribution

  • 00643169699861 ()


  • Bone lever/elevator, reusable
ELEVATOR EX1015003 LAMINAR
MEDTRONIC SOFAMOR DANEK, INC.
EX1015003
In Commercial Distribution

  • 00643169698345 ()


  • Bone lever/elevator, reusable
PROBE EX1015032 THORACIC BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1015032
In Commercial Distribution

  • 00643169698307 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE X1015051 BAYONET BALL SHORT LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X1015051
In Commercial Distribution

  • 00643169698291 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE X1015050 BAYONET BALL SHORT RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X1015050
In Commercial Distribution

  • 00643169698284 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
GUIDE EX1015064 INTRADISCAL DRILL 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1015064
In Commercial Distribution

  • 00643169695870 ()


  • Surgical drill guide, reusable
PROBE EX1015046 STRAIGHT PADDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1015046
In Commercial Distribution

  • 00643169695191 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
SCREWDRIVER EX0915017 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0915017
In Commercial Distribution

  • 00643169694125 ()


  • Surgical screwdriver, reusable
PENFIELD X1015037 6.5 PUSH/PULL
MEDTRONIC SOFAMOR DANEK, INC.
X1015037
In Commercial Distribution

  • 00643169693715 ()


  • Surgical screwdriver, reusable
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