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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AWL EX1212019 VARIABLE ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1212019
In Commercial Distribution

  • 00643169298811 ()


  • Bone awl, reusable
T-HANDLE EX1112119 LATERAL ROD REDUCER
MEDTRONIC SOFAMOR DANEK, INC.
EX1112119
In Commercial Distribution

  • 00643169295902 ()


  • Orthopaedic rod reducer
DISTRACTOR EX1212013 5.5/6.0 PLIERS
MEDTRONIC SOFAMOR DANEK, INC.
EX1212013
In Commercial Distribution

  • 00643169295803 ()


  • Surgical flat-nosed pliers
CURETTE EX1112130 NON-BAYONET STRT RING
MEDTRONIC SOFAMOR DANEK, INC.
EX1112130
In Commercial Distribution

  • 00643169295636 ()


  • Bone curette, reusable
CURETTE EX1112129 NON-BAYONET ANGLE RING
MEDTRONIC SOFAMOR DANEK, INC.
EX1112129
In Commercial Distribution

  • 00643169295629 ()


  • Bone curette, reusable
ROD GRIPPER EX0812326 05.5/6.0 W/ TEETH
MEDTRONIC SOFAMOR DANEK, INC.
EX0812326
In Commercial Distribution

  • 00643169294837 ()


  • Surgical implant/trial-implant/sizer holder, reusable
T- HANDLE EX0712103 4.75 CT W/ TABS
MEDTRONIC SOFAMOR DANEK, INC.
EX0712103
In Commercial Distribution

  • 00643169294813 ()


  • Orthopaedic counter-torque/rod-pushing instrument
SETSCREW DRIVER EX1012313 U-JOINT
MEDTRONIC SOFAMOR DANEK, INC.
EX1012313
In Commercial Distribution

  • 00643169294646 ()


  • Orthopaedic implant driver
STRAIGHT EX1012398 GRAFT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX1012398
In Commercial Distribution

  • 00643169294226 ()


  • Orthopaedic implant impactor, reusable
CALIPERS EX1112043 EXTENDED TIPS
MEDTRONIC SOFAMOR DANEK, INC.
EX1112043
In Commercial Distribution

  • 00643169294004 ()


  • General-purpose calliper, metallic
SLEEVE EX1112018 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1112018
In Commercial Distribution

  • 00643169293953 ()


  • Orthopaedic implant driver
AWL EX1112026 2.43MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1112026
In Commercial Distribution

  • 00643169293915 ()


  • Bone awl, reusable
FUNNEL EX1112021 GRAFT GUN
MEDTRONIC SOFAMOR DANEK, INC.
EX1112021
In Commercial Distribution

  • 00643169293908 ()


  • Bone graft funnel
GUN EX1112020 GRAFT DELIVERY
MEDTRONIC SOFAMOR DANEK, INC.
EX1112020
In Commercial Distribution

  • 00643169293892 ()


  • Bone graft packing block
BENDING EX1112002 IRON
MEDTRONIC SOFAMOR DANEK, INC.
EX1112002
In Commercial Distribution

  • 00643169293885 ()


  • Manual orthopaedic bender, reusable
TAMP EX06124080 SOLID
MEDTRONIC SOFAMOR DANEK, INC.
EX06124080
In Commercial Distribution

  • 00643169293878 ()


  • Surgical tamp, reusable
FUNNEL EX06124079 TEAR DROP
MEDTRONIC SOFAMOR DANEK, INC.
EX06124079
In Commercial Distribution

  • 00643169293861 ()


  • Bone graft funnel
PEDICAL MARKER X0912054 SPHERE
MEDTRONIC SOFAMOR DANEK, INC.
X0912054
In Commercial Distribution

  • 00643169293755 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
RETRACTOR EX1012127 THIN BLADE 17CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012127
In Commercial Distribution

  • 00643169293724 ()


  • Surgical retraction system, reusable
RETRACTOR EX1012124 THIN BLADE 15CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012124
In Commercial Distribution

  • 00643169293694 ()


  • Surgical retraction system, reusable
RETRACTOR EX1012117 HOHMANN BLADE 17CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012117
In Commercial Distribution

  • 00643169293625 ()


  • Surgical retraction system, reusable
RETRACTOR EX1012114 HOHMANN BLADE 14CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012114
In Commercial Distribution

  • 00643169293595 ()


  • Surgical retraction system, reusable
RETRACTOR EX1012110 VESSEL BLADE 20CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012110
In Commercial Distribution

  • 00643169293557 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX1012107 VESSEL BLADE 17CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012107
In Commercial Distribution

  • 00643169293526 ()


  • Surgical retractor/retraction system blade, reusable
PIN EX1012150 STABILITY BLUNT 20CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012150
In Commercial Distribution

  • 00643169293434 ()


  • General internal orthopaedic fixation system implantation kit
PIN EX1012147 STABILITY BLUNT 17CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012147
In Commercial Distribution

  • 00643169293403 ()


  • General internal orthopaedic fixation system implantation kit
PIN EX1012144 STABILITY BLUNT 14CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012144
In Commercial Distribution

  • 00643169293373 ()


  • General internal orthopaedic fixation system implantation kit
RETRACTOR EX1012104 VESSEL BLADE 14CM
MEDTRONIC SOFAMOR DANEK, INC.
EX1012104
In Commercial Distribution

  • 00643169293328 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X1012124 THIN BLADE 14CM
MEDTRONIC SOFAMOR DANEK, INC.
X1012124
In Commercial Distribution

  • 00643169293236 ()


  • Surgical retraction system, reusable
RETRACTOR X1012117 HOHMANN BLADE 17CM
MEDTRONIC SOFAMOR DANEK, INC.
X1012117
In Commercial Distribution

  • 00643169293168 ()


  • Surgical retraction system, reusable
RETRACTOR X1012114 HOHMANN BLADE 14CM
MEDTRONIC SOFAMOR DANEK, INC.
X1012114
In Commercial Distribution

  • 00643169293137 ()


  • Surgical retraction system, reusable
RETRACTOR X1012107 VESSEL BLADE 17CM
MEDTRONIC SOFAMOR DANEK, INC.
X1012107
In Commercial Distribution

  • 00643169293069 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X1012104 VESSEL BLADE 14CM
MEDTRONIC SOFAMOR DANEK, INC.
X1012104
In Commercial Distribution

  • 00643169293021 ()


  • Surgical retractor/retraction system blade, reusable
PIN X1012137 STABILITY 17CM
MEDTRONIC SOFAMOR DANEK, INC.
X1012137
In Commercial Distribution

  • 00643169292864 ()


  • General internal orthopaedic fixation system implantation kit
PIN X1012134 STABILITY 14CM
MEDTRONIC SOFAMOR DANEK, INC.
X1012134
In Commercial Distribution

  • 00643169292833 ()


  • General internal orthopaedic fixation system implantation kit
RETRACTOR X1012127 THIN BLADE 17CM
MEDTRONIC SOFAMOR DANEK, INC.
X1012127
In Commercial Distribution

  • 00643169292765 ()


  • Surgical retraction system, reusable
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
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