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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IMPACTOR EX0816078 5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0816078
In Commercial Distribution

  • 00643169890206 ()


  • Orthopaedic implant impactor, reusable
OSTEOTOME EX1016016 STRAIGHT SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX1016016
In Commercial Distribution

  • 00643169888920 ()


  • Plastic surgery osteotome
RASP EX0916019 9MM X 12MM X 16MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0916019
In Commercial Distribution

  • 00643169888777 ()


  • Bone file/rasp, manual, reusable
RASP EX0916018 8MM X 12MM X 16MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0916018
In Commercial Distribution

  • 00643169888760 ()


  • Bone file/rasp, manual, reusable
AWL X0816047 BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0816047
In Commercial Distribution

  • 00643169885578 ()


  • Bone awl, reusable
SCREWDRIVR X0816101 XTR LNG MAS LCK SLVE
MEDTRONIC SOFAMOR DANEK, INC.
X0816101
In Commercial Distribution

  • 00643169883321 ()


  • General internal orthopaedic fixation system implantation kit
TAP EX0112175 3.0 TAPERED
MEDTRONIC SOFAMOR DANEK, INC.
EX0112175
In Commercial Distribution

  • 00643169133723 ()


  • Bone tap, reusable
DRILL GUIDE EX0112172 40MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112172
In Commercial Distribution

  • 00643169133419 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX0112171 35MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112171
In Commercial Distribution

  • 00643169133402 ()


  • Surgical drill guide, reusable
DRILL GUIDE EX0112170 30MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112170
In Commercial Distribution

  • 00643169133396 ()


  • Surgical drill guide, reusable
DELIVERY TUBE EX0112165 MED 30 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0112165
In Commercial Distribution

  • 00643169132504 ()


  • Bone graft funnel
DELIVERY TUBE EX0112163 SM 30 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0112163
In Commercial Distribution

  • 00643169132481 ()


  • Bone graft funnel
DELIVERY TUBE EX0112162 SM 15 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0112162
In Commercial Distribution

  • 00643169132474 ()


  • Bone graft funnel
DRILL EX0112146 3.5 MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112146
In Commercial Distribution

  • 00643169132443 ()


  • Fluted surgical drill bit, reusable
DRIVER EX0112145 2 MM SQUARE
MEDTRONIC SOFAMOR DANEK, INC.
EX0112145
In Commercial Distribution

  • 00643169132436 ()


  • Orthopaedic implant driver
GUIDE EX0112144 ADJ DRILL
MEDTRONIC SOFAMOR DANEK, INC.
EX0112144
In Commercial Distribution

  • 00643169132429 ()


  • Surgical drill guide, reusable
DRILL EX0112143 1.5 MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112143
In Commercial Distribution

  • 00643169132412 ()


  • Fluted surgical drill bit, reusable
SCRAPER EX1211048 PUSH
MEDTRONIC SOFAMOR DANEK, INC.
EX1211048
In Commercial Distribution

  • 00643169132405 ()


  • Orthopaedic knife
CURETTE EX1211017 LARGE FORWARD ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1211017
In Commercial Distribution

  • 00643169132399 ()


  • Bone curette, reusable
CURETTE EX1211016 LARGE REVERSE ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1211016
In Commercial Distribution

  • 00643169132382 ()


  • Bone curette, reusable
SCREWDRIVER EX1211015 0 DEG ILIO SACRAL
MEDTRONIC SOFAMOR DANEK, INC.
EX1211015
In Commercial Distribution

  • 00643169132375 ()


  • Surgical screwdriver, reusable
REMOVER EX1111156 SCREW
MEDTRONIC SOFAMOR DANEK, INC.
EX1111156
In Commercial Distribution

  • 00643169132269 ()


  • Surgical screwdriver, reusable
GUIDE EX0112054 DUAL DRILLING
MEDTRONIC SOFAMOR DANEK, INC.
EX0112054
In Commercial Distribution

  • 00643169123304 ()


  • Surgical drill guide, reusable
HOLDER EX1211203 3.2MM ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX1211203
In Commercial Distribution

  • 00643169123298 ()


  • Surgical implant/trial-implant/sizer holder, reusable
CALIPER EX1211011 TIP, 45MM OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
EX1211011
In Commercial Distribution

  • 00643169123250 ()


  • General-purpose calliper, metallic
CALIPER EX1211010 TIP, 25MM OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
EX1211010
In Commercial Distribution

  • 00643169123243 ()


  • General-purpose calliper, metallic
CALIPER EX1211009 TIP, 5MM OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
EX1211009
In Commercial Distribution

  • 00643169123236 ()


  • General-purpose calliper, metallic
SPREADER EX1011195 MEASURING HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1011195
In Commercial Distribution

  • 00643169123229 ()


  • Surgical instrument handle, non-torque-limiting
AWL EX1211167 ROUND AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX1211167
In Commercial Distribution

  • 00643169123212 ()


  • Bone awl, reusable
AWL EX1211166 SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX1211166
In Commercial Distribution

  • 00643169123205 ()


  • Bone awl, reusable
CYLINDER EX1111092 PEDICLE MARKER
MEDTRONIC SOFAMOR DANEK, INC.
EX1111092
In Commercial Distribution

  • 00643169123199 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
HOLDER EX1111091 PEDICLE MARKER
MEDTRONIC SOFAMOR DANEK, INC.
EX1111091
In Commercial Distribution

  • 00643169123182 ()


  • Surgical implant/trial-implant/sizer holder, reusable
PROBE EX0112038 DURA
MEDTRONIC SOFAMOR DANEK, INC.
EX0112038
In Commercial Distribution

  • 00643169122123 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
MICROPITUITARY EX1211059 3.0MM SERRATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1211059
In Commercial Distribution

  • 00643169122116 ()


  • Orthopaedic joint/limb rongeur
MICROPITUITARY EX1211058 2.5MM SERRATED
MEDTRONIC SOFAMOR DANEK, INC.
EX1211058
In Commercial Distribution

  • 00643169122109 ()


  • Orthopaedic joint/limb rongeur
CHISEL EX0112119 8MM X 18MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112119
In Commercial Distribution

  • 00643169122093 ()


  • Orthopaedic osteotome
RASP EX1111609 ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX1111609
In Commercial Distribution

  • 00643169121843 ()


  • Bone file/rasp, manual, reusable
HAMMER X0112097 SLAP
MEDTRONIC SOFAMOR DANEK, INC.
X0112097
In Commercial Distribution

  • 00643169121836 ()


  • Orthopaedic implantation hammering attachment
TAP EX0112081 PEAR HANDLE 7.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112081
In Commercial Distribution

  • 00643169121829 ()


  • Bone tap, reusable
TAP EX0112080 PEAR HANDLE 5.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0112080
In Commercial Distribution

  • 00643169121812 ()


  • Bone tap, reusable
MICRO-PENFIELD EX1211012 #1
MEDTRONIC SOFAMOR DANEK, INC.
EX1211012
In Commercial Distribution

  • 00643169121805 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ROD EX0112015 GRIPPER 5.5/6.0 VICE
MEDTRONIC SOFAMOR DANEK, INC.
EX0112015
In Commercial Distribution

  • 00643169121669 ()


  • Surgical flat-nosed pliers
TAP EX0112061 6.5MM INJECTION
MEDTRONIC SOFAMOR DANEK, INC.
EX0112061
In Commercial Distribution

  • 00643169121287 ()


  • Bone tap, reusable
TAP EX0112060 5.5MM INJECTION
MEDTRONIC SOFAMOR DANEK, INC.
EX0112060
In Commercial Distribution

  • 00643169121270 ()


  • Bone tap, reusable
TEMPLATE X0112065 ROD
MEDTRONIC SOFAMOR DANEK, INC.
X0112065
In Commercial Distribution

  • 00643169121263 ()


  • Surgical implant template, reusable
INTRODUCER EX0112068 PLUG
MEDTRONIC SOFAMOR DANEK, INC.
EX0112068
In Commercial Distribution

  • 00643169121249 ()


  • Orthopaedic rod reducer
RETRACTOR EX0112039 NERVE ROOT 7MM WIDE
MEDTRONIC SOFAMOR DANEK, INC.
EX0112039
In Commercial Distribution

  • 00643169121232 ()


  • Surgical retraction system, reusable
KERRISON X0112090 5MM 90 DEG DISASSEMBLE
MEDTRONIC SOFAMOR DANEK, INC.
X0112090
In Commercial Distribution

  • 00643169121225 ()


  • Bone curette, reusable
KERRISON X0112089 4MM 90 DEG DISASSEMBLE
MEDTRONIC SOFAMOR DANEK, INC.
X0112089
In Commercial Distribution

  • 00643169121218 ()


  • Bone curette, reusable
KERRISON X0112088 3MM 90 DEG DISASSEMBLE
MEDTRONIC SOFAMOR DANEK, INC.
X0112088
In Commercial Distribution

  • 00643169121201 ()


  • Bone curette, reusable
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