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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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
FEELER EX1012399 W/ DEPTH MARKING
MEDTRONIC SOFAMOR DANEK, INC.
EX1012399
In Commercial Distribution

  • 00643169279964 ()


  • Orthopaedic bone calliper
SLEEVE EX1012056 SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1012056
In Commercial Distribution

  • 00643169279957 ()


  • Orthopaedic implant driver
DISTRACTOR EX1012042 4.75 TLIF
MEDTRONIC SOFAMOR DANEK, INC.
EX1012042
In Commercial Distribution

  • 00643169279582 ()


  • Orthopaedic surgical distractor, internal
RETRACTOR EX1012001 20MM HINGED
MEDTRONIC SOFAMOR DANEK, INC.
EX1012001
In Commercial Distribution

  • 00643169278394 ()


  • Surgical retractor/retraction system blade, reusable
HEAD POSITIONER EX0912103 6.35MM MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0912103
In Commercial Distribution

  • 00643169278387 ()


  • Orthopaedic fixation implant alignment tool
FORCEP HOLDER EX0912102 6.35 & 7.2MM ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0912102
In Commercial Distribution

  • 00643169278370 ()


  • Surgical implant/trial-implant/sizer holder, reusable
REDUCER EX1012051 HS 5.5-6.0 LGE THB TAB
MEDTRONIC SOFAMOR DANEK, INC.
EX1012051
In Commercial Distribution

  • 00643169277540 ()


  • Orthopaedic rod reducer
PROBE EX0912007 FEELER 2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0912007
In Commercial Distribution

  • 00643169277526 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
STAPLE X1012033 PREFIXATION DUAL PRG SS
MEDTRONIC SOFAMOR DANEK, INC.
X1012033
In Commercial Distribution

  • 00643169277007 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
COUNTER TORQUE EX1012309 LARGE HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1012309
In Commercial Distribution

  • 00643169276994 ()


  • Orthopaedic counter-torque/rod-pushing instrument
AWL EX0812030 RECTRACTABLE EXTENDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0812030
In Commercial Distribution

  • 00643169276970 ()


  • Bone awl, reusable
TAP EX0912124 7.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0912124
In Commercial Distribution

  • 00643169276963 ()


  • Bone tap, reusable
TAP EX0912123 6.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0912123
In Commercial Distribution

  • 00643169276956 ()


  • Bone tap, reusable
TAP EX0912122 5.5MM CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0912122
In Commercial Distribution

  • 00643169276949 ()


  • Bone tap, reusable
DRIVER 9010001261 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
9010001261
In Commercial Distribution

  • 00643169275386 ()


  • Orthopaedic implant driver
TAP 9010001260 12MM
MEDTRONIC SOFAMOR DANEK, INC.
9010001260
In Commercial Distribution

  • 00643169275379 ()


  • Bone tap, reusable
DRILL 9010001250 12MM
MEDTRONIC SOFAMOR DANEK, INC.
9010001250
In Commercial Distribution

  • 00643169275362 ()


  • Fluted surgical drill bit, reusable
DEROTATOR EX0912084 APICAL 4.75
MEDTRONIC SOFAMOR DANEK, INC.
EX0912084
In Commercial Distribution

  • 00643169273535 ()


  • Orthopaedic counter-torque/rod-pushing instrument
HOLDER EX0812335 DLIF RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX0812335
In Commercial Distribution

  • 00643169273504 ()


  • Surgical retractor/retraction system blade, reusable
FOOTED EX0912088 TAMP
MEDTRONIC SOFAMOR DANEK, INC.
EX0912088
In Commercial Distribution

  • 00643169273474 ()


  • Surgical tamp, reusable
TAP X1012003 7.5MM LONG
MEDTRONIC SOFAMOR DANEK, INC.
X1012003
In Commercial Distribution

  • 00643169273467 ()


  • Bone tap, reusable
PROBE X0211139 LONG ILIAC BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0211139
In Commercial Distribution

  • 00643169273306 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
TAP EX1012014 6.5MM - LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX1012014
In Commercial Distribution

  • 00643169273061 ()


  • Bone tap, reusable
TAP EX1012013 5.5MM - LONG
MEDTRONIC SOFAMOR DANEK, INC.
EX1012013
In Commercial Distribution

  • 00643169273054 ()


  • Bone tap, reusable
FLEX X0812933 ARM WO CLAMP COMPONENTS
MEDTRONIC SOFAMOR DANEK, INC.
X0812933
In Commercial Distribution

  • 00643169273047 ()


  • Orthopaedic fixation implant alignment tool
RETRACTOR X0812344 23MM WIDE HAND-HELD
MEDTRONIC SOFAMOR DANEK, INC.
X0812344
In Commercial Distribution

  • 00643169272941 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0812343 20MM WIDE HAND-HELD
MEDTRONIC SOFAMOR DANEK, INC.
X0812343
In Commercial Distribution

  • 00643169272934 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X0812342 18MM WIDE HAND-HELD
MEDTRONIC SOFAMOR DANEK, INC.
X0812342
In Commercial Distribution

  • 00643169272927 ()


  • Surgical retractor/retraction system blade, reusable
DISTRACTOR EX0912011 4MM WEDGE
MEDTRONIC SOFAMOR DANEK, INC.
EX0912011
In Commercial Distribution

  • 00643169271562 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0912010 4MM WEDGE
MEDTRONIC SOFAMOR DANEK, INC.
EX0912010
In Commercial Distribution

  • 00643169271555 ()


  • Orthopaedic surgical distractor, internal
DRILL GUIDE EX0912015 VARIABLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0912015
In Commercial Distribution

  • 00643169271548 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX0912014 FIXED
MEDTRONIC SOFAMOR DANEK, INC.
EX0912014
In Commercial Distribution

  • 00643169271531 ()


  • Surgical drill guide, reusable
DRIVER 9010000144 BONE SCREW ADJUSTMENT
MEDTRONIC SOFAMOR DANEK, INC.
9010000144
In Commercial Distribution

  • 00613994694041 ()


  • Surgical screwdriver, reusable
RASP X0707110
MEDTRONIC SOFAMOR DANEK, INC.
X0707110
In Commercial Distribution

  • 00613994687470 ()


  • Bone file/rasp, manual, reusable
PROBE X0509534 RIGID HOLT
MEDTRONIC SOFAMOR DANEK, INC.
X0509534
In Commercial Distribution

  • 00613994686671 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
ADJUSTER 9391300 IN SITU
MEDTRONIC SOFAMOR DANEK, INC.
9391300
In Commercial Distribution

  • 00613994683717 ()


  • Orthopaedic fixation implant alignment tool
REMOVER 9401200 END CAP REMOVER
MEDTRONIC SOFAMOR DANEK, INC.
9401200
In Commercial Distribution

  • 00613994683601 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
INSERTER 9411600 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9411600
In Commercial Distribution

  • 00613994683588 ()

  • Outer Diameter: 16.0 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSERTER 9411900 19MM
MEDTRONIC SOFAMOR DANEK, INC.
9411900
In Commercial Distribution

  • 00613994683571 ()

  • Outer Diameter: 19.0 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSERTER 9412500 25MM
MEDTRONIC SOFAMOR DANEK, INC.
9412500
In Commercial Distribution

  • 00613994683557 ()

  • Outer Diameter: 25.0 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable
AWL X1108166 FIXED ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
X1108166
In Commercial Distribution

  • 00613994683182 ()


  • Bone awl, reusable
PROBE X0507383 LUMBAR GROOVED
MEDTRONIC SOFAMOR DANEK, INC.
X0507383
In Commercial Distribution

  • 00613994667588 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
TRIAL 9877710 LORDOTIC 3-HOLE 39/41MM
MEDTRONIC SOFAMOR DANEK, INC.
9877710
In Commercial Distribution

  • 00613994666611 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL 9877708 LORDOTIC 3-HOLE 33/35MM
MEDTRONIC SOFAMOR DANEK, INC.
9877708
In Commercial Distribution

  • 00613994666598 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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