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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TRIAL 9010000578 ISP CORTICAL WEDGE 8MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000578
In Commercial Distribution

  • 00643169364936 ()


  • Surgical implant template, reusable
TRIAL 9010000575 SUPPLEMENTAL 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000575
In Commercial Distribution

  • 00643169364929 ()


  • Surgical implant template, reusable
TRIAL 9010000574 SUPPLEMENTAL 12MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000574
In Commercial Distribution

  • 00643169364912 ()


  • Surgical implant template, reusable
TRIAL 9010000573 SUPPLEMENTAL 10MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000573
In Commercial Distribution

  • 00643169364905 ()


  • Surgical implant template, reusable
INSERTER 9010000570 ISP WEDGE
MEDTRONIC SOFAMOR DANEK, INC.
9010000570
In Commercial Distribution

  • 00643169364875 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
REMOVER EX0313115 SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX0313115
In Commercial Distribution

  • 00643169364868 ()


  • Orthopaedic implantation sleeve, reusable
DRIVER EX0413085 SETSCREW BREAKOFF
MEDTRONIC SOFAMOR DANEK, INC.
EX0413085
In Commercial Distribution

  • 00643169362833 ()


  • Orthopaedic implant driver
RETRACTOR EX0513002 24MM HAND HELD
MEDTRONIC SOFAMOR DANEK, INC.
EX0513002
In Commercial Distribution

  • 00643169360822 ()


  • Surgical retractor/retraction system blade, reusable
DISTRACTOR X0213194 LEFT HANDED
MEDTRONIC SOFAMOR DANEK, INC.
X0213194
In Commercial Distribution

  • 00643169360280 ()


  • Orthopaedic surgical distractor, internal
TAMP 9010000412 BONE
MEDTRONIC SOFAMOR DANEK, INC.
9010000412
In Commercial Distribution

  • 00643169359024 ()


  • Surgical tamp, reusable
FUNNEL 9010000411 BONE
MEDTRONIC SOFAMOR DANEK, INC.
9010000411
In Commercial Distribution

  • 00643169359017 ()


  • Bone graft funnel
PIN EX0613001 PLATE HOLDING
MEDTRONIC SOFAMOR DANEK, INC.
EX0613001
In Commercial Distribution

  • 00643169358966 ()


  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER EX0313018 SHORT L6.35 MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0313018
In Commercial Distribution

  • 00643169358959 ()


  • Orthopaedic implant driver
FUNNEL EX0413246 GRAFT ASSEMBLY
MEDTRONIC SOFAMOR DANEK, INC.
EX0413246
In Commercial Distribution

  • 00643169358645 ()


  • Bone graft funnel
RETRACTOR EX0513104 TISSUE
MEDTRONIC SOFAMOR DANEK, INC.
EX0513104
In Commercial Distribution

  • 00643169358454 ()


  • Surgical retractor/retraction system blade, reusable
SCREWDRIVER EX0413086 CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0413086
In Commercial Distribution

  • 00643169358447 ()


  • Orthopaedic implant driver
RETRACTOR EX0513069 TUBULAR 90MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513069
In Commercial Distribution

  • 00643169356726 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513068 TUBULAR 80MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513068
In Commercial Distribution

  • 00643169356719 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513067 TUBULAR 70MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513067
In Commercial Distribution

  • 00643169356702 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513066 TUBULAR 60MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513066
In Commercial Distribution

  • 00643169356696 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513063 TUBULAR 30MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513063
In Commercial Distribution

  • 00643169356689 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513065 TUBULAR 50MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513065
In Commercial Distribution

  • 00643169356672 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0513064 TUBULAR 40MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX0513064
In Commercial Distribution

  • 00643169356665 ()


  • Surgical retractor/retraction system blade, reusable
POSITIONER X0513100 5.5 MAS HEAD
MEDTRONIC SOFAMOR DANEK, INC.
X0513100
In Commercial Distribution

  • 00643169356658 ()


  • Orthopaedic fixation implant alignment tool
REAMER EX0513132 BONE CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0513132
In Commercial Distribution

  • 00643169356382 ()


  • Orthopaedic broach
DRILL X0513109 GUIDE FIXED
MEDTRONIC SOFAMOR DANEK, INC.
X0513109
In Commercial Distribution

  • 00643169356337 ()


  • Surgical drill guide, reusable
DRILL X0513107 16 MM BIT
MEDTRONIC SOFAMOR DANEK, INC.
X0513107
In Commercial Distribution

  • 00643169356313 ()


  • Fluted surgical drill bit, reusable
DRILL X0513106 14 MM BIT
MEDTRONIC SOFAMOR DANEK, INC.
X0513106
In Commercial Distribution

  • 00643169356306 ()


  • Fluted surgical drill bit, reusable
DRILL X0513105 12 MM BIT
MEDTRONIC SOFAMOR DANEK, INC.
X0513105
In Commercial Distribution

  • 00643169356290 ()


  • Fluted surgical drill bit, reusable
CURETTE EX0511075 CUP ANGLED UP SIZE 5
MEDTRONIC SOFAMOR DANEK, INC.
EX0511075
In Commercial Distribution

  • 00643169035959 ()


  • Bone curette, reusable
CURETTE EX0511074 CUP LEFT SIZE 5
MEDTRONIC SOFAMOR DANEK, INC.
EX0511074
In Commercial Distribution

  • 00643169035942 ()


  • Bone curette, reusable
CURETTE EX0511073 CUP RIGHT SIZE 5
MEDTRONIC SOFAMOR DANEK, INC.
EX0511073
In Commercial Distribution

  • 00643169035935 ()


  • Bone curette, reusable
ELEVATOR EX0511072 DL COBB 18MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0511072
In Commercial Distribution

  • 00643169035928 ()


  • Bone lever/elevator, reusable
TRAY 9563206 RAPID MIDLINE
MEDTRONIC SOFAMOR DANEK, INC.
9563206
In Commercial Distribution

  • 00643169035898 ()


  • Instrument tray, reusable
DRIVER EX0611088 EXPANDING T27
MEDTRONIC SOFAMOR DANEK, INC.
EX0611088
In Commercial Distribution

  • 00643169035690 ()


  • Surgical drill guide, reusable
PROBE EX0511131 BALL HANDLE THORACIC
MEDTRONIC SOFAMOR DANEK, INC.
EX0511131
In Commercial Distribution

  • 00643169035645 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
BENDER EX0711007 LEFT 20/45 IN-SITU
MEDTRONIC SOFAMOR DANEK, INC.
EX0711007
In Commercial Distribution

  • 00643169035447 ()


  • Manual orthopaedic bender, reusable
BENDER EX0711006 RIGHT 20/45 IN-SITU
MEDTRONIC SOFAMOR DANEK, INC.
EX0711006
In Commercial Distribution

  • 00643169035430 ()


  • Manual orthopaedic bender, reusable
DILATOR X0611293 24.8MM
MEDTRONIC SOFAMOR DANEK, INC.
X0611293
In Commercial Distribution

  • 00643169035164 ()


  • Laparoscopic access cannula dilator
DISTRACTOR EX0611011 11X14X11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0611011
In Commercial Distribution

  • 00643169035089 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0611010 10X14X11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0611010
In Commercial Distribution

  • 00643169035072 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0611009 9X14X11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0611009
In Commercial Distribution

  • 00643169035065 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0611008 8X14X11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0611008
In Commercial Distribution

  • 00643169035058 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0611007 7X14X11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0611007
In Commercial Distribution

  • 00643169035041 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0611006 6X14X11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0611006
In Commercial Distribution

  • 00643169035034 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0611005 5X14X11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0611005
In Commercial Distribution

  • 00643169035027 ()


  • Orthopaedic surgical distractor, internal
CURETTE EX0411140 DLIF UTERINE SZ 4
MEDTRONIC SOFAMOR DANEK, INC.
EX0411140
In Commercial Distribution

  • 00643169035010 ()


  • Bone curette, reusable
BLADE EX0611142 16CM SHOEHORN
MEDTRONIC SOFAMOR DANEK, INC.
EX0611142
In Commercial Distribution

  • 00643169026988 ()


  • Orthopaedic knife
BLADE EX0611141 15CM SHOEHORN
MEDTRONIC SOFAMOR DANEK, INC.
EX0611141
In Commercial Distribution

  • 00643169026971 ()


  • Orthopaedic knife
BLADE EX0611140 14CM SHOEHORN
MEDTRONIC SOFAMOR DANEK, INC.
EX0611140
In Commercial Distribution

  • 00643169026964 ()


  • Orthopaedic knife
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