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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ASM EX1111148 5.5 EXTERNAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1111148
In Commercial Distribution

  • 00643169106468 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ASM EX1111147 5.5 INTERNAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1111147
In Commercial Distribution

  • 00643169106451 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TAP X1111568 3.0MM QUICK CONNECT
MEDTRONIC SOFAMOR DANEK, INC.
X1111568
In Commercial Distribution

  • 00643169106444 ()


  • Bone tap, reusable
INTRODUCER EX1111001 LOW PROFILE ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1111001
In Commercial Distribution

  • 00643169106413 ()


  • Orthopaedic counter-torque/rod-pushing instrument
ADJUSTER EX1111573 HEAD W SILCONE HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1111573
In Commercial Distribution

  • 00643169106406 ()


  • Surgical instrument handle, non-torque-limiting
GUIDE EX1111031 DRILL
MEDTRONIC SOFAMOR DANEK, INC.
EX1111031
In Commercial Distribution

  • 00643169106031 ()


  • Surgical drill guide, reusable
INTRODUCER EX1111572 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1111572
In Commercial Distribution

  • 00643169106024 ()


  • Surgical flat-nosed pliers
CURETTE X1111563 2.7MM 90 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
X1111563
In Commercial Distribution

  • 00643169106017 ()


  • Bone curette, reusable
REDUCER EX1111020 T HANDLE LATERAL ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1111020
In Commercial Distribution

  • 00643169106000 ()


  • Surgical instrument handle, non-torque-limiting
DRILL GUIDE EX111081 FIXED ANGLE SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX111081
In Commercial Distribution

  • 00643169104631 ()


  • Surgical drill guide, reusable
DISTRACTOR EX1111160 TIP 10MM 12DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111160
In Commercial Distribution

  • 00643169104624 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111161 TIP 12MM 12DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111161
In Commercial Distribution

  • 00643169104617 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111162 TIP 14MM 12DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111162
In Commercial Distribution

  • 00643169104600 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111163 TIP 16MM 12DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111163
In Commercial Distribution

  • 00643169104594 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111164 TIP 18MM 12DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111164
In Commercial Distribution

  • 00643169104587 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111165 TIP 20MM 12DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111165
In Commercial Distribution

  • 00643169104570 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111166 TIP 10MM 8DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111166
In Commercial Distribution

  • 00643169104563 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111167 TIP 12MM 8DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111167
In Commercial Distribution

  • 00643169104556 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111168 TIP 14MM 8DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111168
In Commercial Distribution

  • 00643169104549 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111169 TIP 16MM 8DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111169
In Commercial Distribution

  • 00643169104532 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111170 TIP 18MM 8DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111170
In Commercial Distribution

  • 00643169104525 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX1111171 TIP 20MM 8DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX1111171
In Commercial Distribution

  • 00643169104518 ()


  • Orthopaedic surgical distractor, internal
RETRACTOR X1011025 T-BAR/70MM BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1011025
In Commercial Distribution

  • 00643169104501 ()


  • Orthopaedic knife
RETRACTOR X1011024 80MM POST/90MM BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1011024
In Commercial Distribution

  • 00643169104495 ()


  • Orthopaedic knife
RETRACTOR X1011023 70MM POST/80MM BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1011023
In Commercial Distribution

  • 00643169104488 ()


  • Orthopaedic knife
TAP EX0112175 3.0 TAPERED
MEDTRONIC SOFAMOR DANEK, INC.
EX0112175
In Commercial Distribution

  • 00643169133723 ()


  • Bone tap, reusable
SCREWDRIVER EX1211088 4.75 MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1211088
In Commercial Distribution

  • 00643169110755 ()


  • Orthopaedic implant driver
SCREWDRIVER EX1111152 4.75 MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1111152
In Commercial Distribution

  • 00643169110748 ()


  • Orthopaedic implant driver
DISTRACTOR TIP EX1211158 BOTTOM
MEDTRONIC SOFAMOR DANEK, INC.
EX1211158
In Commercial Distribution

  • 00643169110649 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR TIP EX1211157 TOP
MEDTRONIC SOFAMOR DANEK, INC.
EX1211157
In Commercial Distribution

  • 00643169110632 ()


  • Orthopaedic surgical distractor, internal
RED MAS COUNTER TORQUE EX1111547 4.75
MEDTRONIC SOFAMOR DANEK, INC.
EX1111547
In Commercial Distribution

  • 00643169110618 ()


  • Orthopaedic counter-torque/rod-pushing instrument
INSERTER EX1211090 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1211090
In Commercial Distribution

  • 00643169110182 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
SCREWDRIVER X1111594 SS SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1111594
In Commercial Distribution

  • 00643169110175 ()


  • Orthopaedic implant driver
SCREWDRIVER X1111593 SS
MEDTRONIC SOFAMOR DANEK, INC.
X1111593
In Commercial Distribution

  • 00643169110168 ()


  • Orthopaedic implant driver
GUIDEWIRE X1011150 THREADED W MARKINGS
MEDTRONIC SOFAMOR DANEK, INC.
X1011150
In Commercial Distribution

  • 00643169110038 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX1111549 RMAS BREAKOFF
MEDTRONIC SOFAMOR DANEK, INC.
EX1111549
In Commercial Distribution

  • 00643169109872 ()


  • Orthopaedic implant driver
DRILL GUIDE EX1111597 FIXED ANGLE - 14MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1111597
In Commercial Distribution

  • 00643169109841 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX1111596 FIXED ANGLE - 12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1111596
In Commercial Distribution

  • 00643169109834 ()


  • Surgical drill guide, reusable
AWL X0812310 SILICONE HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0812310
In Commercial Distribution

  • 00643169233935 ()


  • Bone awl, reusable
GRIPPER X0712187 4.75 ROD
MEDTRONIC SOFAMOR DANEK, INC.
X0712187
In Commercial Distribution

  • 00643169233928 ()


  • Surgical flat-nosed pliers
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