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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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
BONE X0810542 FUNNEL TAMP
MEDTRONIC SOFAMOR DANEK, INC.
X0810542
In Commercial Distribution

  • 00643169313408 ()


  • Surgical tamp, reusable
BENDER EX0213009 SMALL TUBULAR ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0213009
In Commercial Distribution

  • 00643169313354 ()


  • Manual orthopaedic bender, reusable
PELVIC X1110153 SURGICAL GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1110153
In Commercial Distribution

  • 00643169311145 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER X1212033 T27 UNIVERSAL JOINT
MEDTRONIC SOFAMOR DANEK, INC.
X1212033
In Commercial Distribution

  • 00643169310049 ()


  • Orthopaedic implant driver
3.0MM TAP X1212046 SHAFT NON- STERILE
MEDTRONIC SOFAMOR DANEK, INC.
X1212046
In Commercial Distribution

  • 00643169309906 ()


  • Bone tap, reusable
9MM X0113109 NERVE RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0113109
In Commercial Distribution

  • 00643169309890 ()


  • Surgical retractor/retraction system blade, reusable
12MM X0113112 NERVE RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0113112
In Commercial Distribution

  • 00643169309883 ()


  • Surgical retractor/retraction system blade, reusable
6MM X0113106 NERVE RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0113106
In Commercial Distribution

  • 00643169309876 ()


  • Surgical retractor/retraction system blade, reusable
REAMER X0710022 POST GUIDED
MEDTRONIC SOFAMOR DANEK, INC.
X0710022
In Commercial Distribution

  • 00643169309869 ()


  • Orthopaedic broach
FLAT TIP EX0912051 NERVE ROOT RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX0912051
In Commercial Distribution

  • 00643169309234 ()


  • Surgical retractor/retraction system blade, reusable
DRIVER X1212007 PEEK MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1212007
In Commercial Distribution

  • 00643169309159 ()


  • Orthopaedic implant driver
DRIVER X1212006 6.35 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1212006
In Commercial Distribution

  • 00643169309142 ()


  • Orthopaedic implant driver
DRIVER X1212005 5.5 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1212005
In Commercial Distribution

  • 00643169309135 ()


  • Orthopaedic implant driver
MARKER X0113140 PEDICLE
MEDTRONIC SOFAMOR DANEK, INC.
X0113140
In Commercial Distribution

  • 00643169309128 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
DRIVER EX1012404 PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1012404
In Commercial Distribution

  • 00643169309111 ()


  • Orthopaedic implant driver
PASSER EX1012403 CONNECTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX1012403
In Commercial Distribution

  • 00643169309104 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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