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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PLATE HOLDER EX0213120 CERVICAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0213120
In Commercial Distribution

  • 00643169325968 ()


  • Surgical implant/trial-implant/sizer holder, reusable
RIGHT EX0113026 CORONAL PLANE BENDER
MEDTRONIC SOFAMOR DANEK, INC.
EX0113026
In Commercial Distribution

  • 00643169325944 ()


  • Manual orthopaedic bender, reusable
LEFT EX0113025 CORONAL PLANE BENDER
MEDTRONIC SOFAMOR DANEK, INC.
EX0113025
In Commercial Distribution

  • 00643169325937 ()


  • Manual orthopaedic bender, reusable
EXTENDER EX0213039 SCREW 11CM - 4.75MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0213039
In Commercial Distribution

  • 00643169324145 ()


  • General internal orthopaedic fixation system implantation kit
EXTENDER EX0213038 SCREW 10CM - 4.75MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0213038
In Commercial Distribution

  • 00643169324138 ()


  • General internal orthopaedic fixation system implantation kit
EXTENDER EX0213037 SCREW 9CM - 4.75MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0213037
In Commercial Distribution

  • 00643169324121 ()


  • General internal orthopaedic fixation system implantation kit
EXTENDER EX0213036 SCREW 8CM - 4.75MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0213036
In Commercial Distribution

  • 00643169324114 ()


  • General internal orthopaedic fixation system implantation kit
EXTENDER EX0213035 SCREW 7CM - 4.75MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0213035
In Commercial Distribution

  • 00643169324107 ()


  • General internal orthopaedic fixation system implantation kit
RETRACTOR EX0213112 WIDE TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0213112
In Commercial Distribution

  • 00643169323254 ()


  • Surgical retractor/retraction system blade, reusable
DRILL BIT X0213054 14MM TRI FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0213054
In Commercial Distribution

  • 00643169323247 ()


  • Fluted surgical drill bit, reusable
DRILL BIT X0213057 17MM TRI FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0213057
In Commercial Distribution

  • 00643169323230 ()


  • Fluted surgical drill bit, reusable
DRILL BIT X0213056 16MM TRI FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0213056
In Commercial Distribution

  • 00643169323223 ()


  • Fluted surgical drill bit, reusable
DRILL BIT X0213055 15MM TRI FLAT
MEDTRONIC SOFAMOR DANEK, INC.
X0213055
In Commercial Distribution

  • 00643169323216 ()


  • Fluted surgical drill bit, reusable
COLLET EX1012484 WITH HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1012484
In Commercial Distribution

  • 00643169323018 ()


  • Surgical instrument handle, non-torque-limiting
RING CURETTE X0812028 8MM RIGHT HANDED
MEDTRONIC SOFAMOR DANEK, INC.
X0812028
In Commercial Distribution

  • 00643169322967 ()


  • Bone curette, reusable
TAP EX0113116 3.0 SMALL DIAMETER TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0113116
In Commercial Distribution

  • 00643169322325 ()


  • Bone tap, reusable
LARGE X0113202 ROTATE CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0113202
In Commercial Distribution

  • 00643169322288 ()


  • Orthopaedic knife
MEDIUM X0113201 ROTATE CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0113201
In Commercial Distribution

  • 00643169322271 ()


  • Orthopaedic knife
SMALL X0113200 ROTATE CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
X0113200
In Commercial Distribution

  • 00643169322264 ()


  • Orthopaedic knife
TAMP EX0213177 BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0213177
In Commercial Distribution

  • 00643169322257 ()


  • Surgical tamp, reusable
TAMP EX0213176 ANGLED BONE GRAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0213176
In Commercial Distribution

  • 00643169322240 ()


  • Surgical tamp, reusable
RASP EX0113127 CONVEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0113127
In Commercial Distribution

  • 00643169322189 ()


  • Bone file/rasp, manual, reusable
SET SCREW EX0213010 RETAINING DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0213010
In Commercial Distribution

  • 00643169322134 ()


  • Orthopaedic implant driver
DISTRACTOR EX1112065 4.75 TLIF
MEDTRONIC SOFAMOR DANEK, INC.
EX1112065
In Commercial Distribution

  • 00643169320345 ()


  • Orthopaedic surgical distractor, internal
5.5 STRAIGHT EX0213028 IMPLANT HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
EX0213028
In Commercial Distribution

  • 00643169319622 ()


  • Surgical implant/trial-implant/sizer holder, reusable
DILATOR EX1112025 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1112025
In Commercial Distribution

  • 00643169318861 ()


  • Laparoscopic access cannula dilator
DILATOR EX1112024 CORE
MEDTRONIC SOFAMOR DANEK, INC.
EX1112024
In Commercial Distribution

  • 00643169318854 ()


  • Laparoscopic access cannula dilator
DILATOR EX1112023 HANDGRIP
MEDTRONIC SOFAMOR DANEK, INC.
EX1112023
In Commercial Distribution

  • 00643169318847 ()


  • Laparoscopic access cannula dilator
DTS GUIDE EX1112003 VAR. SINGLE BARREL
MEDTRONIC SOFAMOR DANEK, INC.
EX1112003
In Commercial Distribution

  • 00643169316737 ()


  • General internal orthopaedic fixation system implantation kit
TAMP EX1212053 CURVED 14MM X 6MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1212053
In Commercial Distribution

  • 00643169315853 ()


  • Surgical tamp, reusable
STRAIGHT EX0113035 IMPLANT HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
EX0113035
In Commercial Distribution

  • 00643169315846 ()


  • Surgical implant/trial-implant/sizer holder, reusable
DILATOR X1012401 24.8MM X 200MM
MEDTRONIC SOFAMOR DANEK, INC.
X1012401
In Commercial Distribution

  • 00643169315686 ()


  • Laparoscopic access cannula dilator
RASP EX0113020 BAYONETTED
MEDTRONIC SOFAMOR DANEK, INC.
EX0113020
In Commercial Distribution

  • 00643169313484 ()


  • Bone file/rasp, manual, reusable
DISTRACTOR EX0113019 10MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0113019
In Commercial Distribution

  • 00643169313477 ()


  • Orthopaedic surgical distractor, internal
RASP EX0113018 9MM X 13MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0113018
In Commercial Distribution

  • 00643169313460 ()


  • Bone file/rasp, manual, reusable
RASP EX0113017 8MM X 12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0113017
In Commercial Distribution

  • 00643169313453 ()


  • Bone file/rasp, manual, reusable
RASP EX0113016 7MM X 11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0113016
In Commercial Distribution

  • 00643169313446 ()


  • Bone file/rasp, manual, reusable
IMPACTOR EX0113015 TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0113015
In Commercial Distribution

  • 00643169313439 ()


  • Orthopaedic implant impactor, reusable
RETRACTOR EX0113014 SQ TUBULAR 10X14
MEDTRONIC SOFAMOR DANEK, INC.
EX0113014
In Commercial Distribution

  • 00643169313422 ()


  • Surgical retractor/retraction system blade, reusable
DRILL BIT EX0113013 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0113013
In Commercial Distribution

  • 00643169313415 ()


  • Fluted surgical drill bit, reusable
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