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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TAP EX1112014 7.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1112014
In Commercial Distribution

  • 00643169292581 ()


  • Bone tap, reusable
TAP EX1012055 6.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1012055
In Commercial Distribution

  • 00643169292536 ()


  • Bone tap, reusable
DISTRACTOR EX1112049 LAMINAR SPREADER
MEDTRONIC SOFAMOR DANEK, INC.
EX1112049
In Commercial Distribution

  • 00643169292185 ()


  • Bone distraction forceps
PLUG EX1012315 STARTER
MEDTRONIC SOFAMOR DANEK, INC.
EX1012315
In Commercial Distribution

  • 00643169292178 ()


  • Orthopaedic instrument surgical connector
LINK EX1112053 SEGMENTAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1112053
In Commercial Distribution

  • 00643169292130 ()


  • Orthopaedic fixation implant alignment tool
TAMP EX06124088 BONE
MEDTRONIC SOFAMOR DANEK, INC.
EX06124088
In Commercial Distribution

  • 00643169291508 ()


  • Surgical tamp, reusable
CHISEL EX1112005 FREE HAND, SIZE 6-SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX1112005
In Commercial Distribution

  • 00643169291492 ()


  • Orthopaedic osteotome
CHISEL EX1112004 FREE HAND, SIZE 6-LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX1112004
In Commercial Distribution

  • 00643169291485 ()


  • Orthopaedic osteotome
TAPERED TIP EX0912046 4.0MM TAP SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0912046
In Commercial Distribution

  • 00643169291065 ()


  • Bone tap, reusable
TAPERED TIP EX0912045 3.5MM TAP SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0912045
In Commercial Distribution

  • 00643169291058 ()


  • Bone tap, reusable
TAPERED TIP EX0912044 3.0MM TAP SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0912044
In Commercial Distribution

  • 00643169291041 ()


  • Bone tap, reusable
SCREWDRIVER EX0812005 SLEEVED - 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0812005
In Commercial Distribution

  • 00643169289994 ()


  • Orthopaedic implant driver
GUIDE EX1012305 14MM TAPERED DRILL
MEDTRONIC SOFAMOR DANEK, INC.
EX1012305
In Commercial Distribution

  • 00643169288539 ()


  • Surgical drill guide, reusable
GUIDE EX1012304 TAPERED ADJUSTABLE DRILL
MEDTRONIC SOFAMOR DANEK, INC.
EX1012304
In Commercial Distribution

  • 00643169288522 ()


  • Surgical drill guide, reusable
COBB EX0912034 18MM 15DEG ANG DOWN
MEDTRONIC SOFAMOR DANEK, INC.
EX0912034
In Commercial Distribution

  • 00643169283251 ()


  • Bone lever/elevator, reusable
COBB EX0912033 18MM 15DEG ANG UP
MEDTRONIC SOFAMOR DANEK, INC.
EX0912033
In Commercial Distribution

  • 00643169283244 ()


  • Bone lever/elevator, reusable
HANDLE EX0812921 DRILL GUIDE TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0812921
In Commercial Distribution

  • 00643169281370 ()


  • Surgical drill guide, reusable
GUIDE EX0812325 DRILL TRIAL 10X14X11
MEDTRONIC SOFAMOR DANEK, INC.
EX0812325
In Commercial Distribution

  • 00643169281363 ()


  • Surgical drill guide, reusable
GUIDE EX0812324 DRILL TRIAL 9X14X11
MEDTRONIC SOFAMOR DANEK, INC.
EX0812324
In Commercial Distribution

  • 00643169281356 ()


  • Surgical drill guide, reusable
GUIDE EX0812323 DRILL TRIAL 8X14X11
MEDTRONIC SOFAMOR DANEK, INC.
EX0812323
In Commercial Distribution

  • 00643169281349 ()


  • Surgical drill guide, reusable
GUIDE EX0812322 DRILL TRIAL 7X14X11
MEDTRONIC SOFAMOR DANEK, INC.
EX0812322
In Commercial Distribution

  • 00643169281332 ()


  • Surgical drill guide, reusable
GUIDE EX0812321 DRILL TRIAL 6X14X11
MEDTRONIC SOFAMOR DANEK, INC.
EX0812321
In Commercial Distribution

  • 00643169281325 ()


  • Surgical drill guide, reusable
GUIDE EX0812320 DRILL TRIAL 5X14X11
MEDTRONIC SOFAMOR DANEK, INC.
EX0812320
In Commercial Distribution

  • 00643169281318 ()


  • Surgical drill guide, reusable
CLIP EX1012400 DRILL STOP
MEDTRONIC SOFAMOR DANEK, INC.
EX1012400
In Commercial Distribution

  • 00643169281295 ()


  • Fluted surgical drill bit, reusable
RASP EX1112010 INTERVERTEBRAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1112010
In Commercial Distribution

  • 00643169280731 ()


  • Bone file/rasp, manual, reusable
CORONAL PLANE BENDER EX1012303 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX1012303
In Commercial Distribution

  • 00643169280304 ()


  • Manual orthopaedic bender, reusable
CORONAL PLANE BENDER EX1012302 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1012302
In Commercial Distribution

  • 00643169280298 ()


  • Manual orthopaedic bender, reusable
RETRACTOR X0912079 9CM HOOK
MEDTRONIC SOFAMOR DANEK, INC.
X0912079
In Commercial Distribution

  • 00643169280199 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0912078 8CM HOOK
MEDTRONIC SOFAMOR DANEK, INC.
X0912078
In Commercial Distribution

  • 00643169280182 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0912077 7CM HOOK
MEDTRONIC SOFAMOR DANEK, INC.
X0912077
In Commercial Distribution

  • 00643169280175 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0912075 5CM HOOK
MEDTRONIC SOFAMOR DANEK, INC.
X0912075
In Commercial Distribution

  • 00643169280151 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0912074 4CM HOOK
MEDTRONIC SOFAMOR DANEK, INC.
X0912074
In Commercial Distribution

  • 00643169280144 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0912073 3CM HOOK
MEDTRONIC SOFAMOR DANEK, INC.
X0912073
In Commercial Distribution

  • 00643169280137 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X09120710 10CM HOOK
MEDTRONIC SOFAMOR DANEK, INC.
X09120710
In Commercial Distribution

  • 00643169280120 ()


  • Surgical retractor/retraction system blade, reusable
BLADE X0912070 EXTRA NARROW 11CM
MEDTRONIC SOFAMOR DANEK, INC.
X0912070
In Commercial Distribution

  • 00643169280113 ()


  • Orthopaedic knife
BLADE X0912069 EXTRA NARROW 9CM
MEDTRONIC SOFAMOR DANEK, INC.
X0912069
In Commercial Distribution

  • 00643169280106 ()


  • Orthopaedic knife
BLADE X0912068 EXTRA NARROW 7CM
MEDTRONIC SOFAMOR DANEK, INC.
X0912068
In Commercial Distribution

  • 00643169280090 ()


  • Orthopaedic knife
TAP EX0912093 4.0MM SOLID
MEDTRONIC SOFAMOR DANEK, INC.
EX0912093
In Commercial Distribution

  • 00643169280083 ()


  • Bone tap, reusable
TAP EX0912092 3.75MM SOLID
MEDTRONIC SOFAMOR DANEK, INC.
EX0912092
In Commercial Distribution

  • 00643169280076 ()


  • Bone tap, reusable
TAP EX0912094 4.5MM SOLID
MEDTRONIC SOFAMOR DANEK, INC.
EX0912094
In Commercial Distribution

  • 00643169280069 ()


  • Bone tap, reusable
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