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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RETRACTOR EX0610213 18MMX90MM EXPANDING
MEDTRONIC SOFAMOR DANEK, INC.
EX0610213
In Commercial Distribution

  • 00613994842824 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0610212 18MMX80MM EXPANDING
MEDTRONIC SOFAMOR DANEK, INC.
EX0610212
In Commercial Distribution

  • 00613994842817 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX0610210 18MMX60MM EXPANDING
MEDTRONIC SOFAMOR DANEK, INC.
EX0610210
In Commercial Distribution

  • 00613994842794 ()


  • Surgical retractor/retraction system blade, reusable
OPENER EX0609463 18MMX80MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0609463
In Commercial Distribution

  • 00613994842770 ()


  • Surgical retractor/retraction system blade, reusable
OPENER EX0609461 18MMX40MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0609461
In Commercial Distribution

  • 00613994842756 ()


  • Surgical retractor/retraction system blade, reusable
DISTRACTOR X0710023 W BREAKAWAY HANDLES
MEDTRONIC SOFAMOR DANEK, INC.
X0710023
In Commercial Distribution

  • 00613994842480 ()


  • Orthopaedic surgical distractor, internal
POSITIONER EX0510284 5.5 ROD WITH CLAMP
MEDTRONIC SOFAMOR DANEK, INC.
EX0510284
In Commercial Distribution

  • 00613994842091 ()


  • Orthopaedic fixation implant alignment tool
HANDLE EX0410311 REMOVEABLE B/O LARGE
MEDTRONIC SOFAMOR DANEK, INC.
EX0410311
In Commercial Distribution

  • 00613994840776 ()


  • Surgical instrument handle, non-torque-limiting
CURETTE EX0610276 3.6MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0610276
In Commercial Distribution

  • 00613994840745 ()


  • Bone curette, reusable
DRIVER EX0610298 GENERAL SS MPA
MEDTRONIC SOFAMOR DANEK, INC.
EX0610298
In Commercial Distribution

  • 00613994840141 ()


  • Orthopaedic implant driver
TRIAL EX0610134 4MMX14MMX11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0610134
In Commercial Distribution

  • 00613994840134 ()


  • Surgical implant template, reusable
BLADE EX0510075 1.8MMDIATAPEREDPTDHOOK
MEDTRONIC SOFAMOR DANEK, INC.
EX0510075
In Commercial Distribution

  • 00613994840028 ()


  • Orthopaedic knife
BLADE EX0510074 1.8MMDIATAPEREDPTDHOOK
MEDTRONIC SOFAMOR DANEK, INC.
EX0510074
In Commercial Distribution

  • 00613994840011 ()


  • Orthopaedic knife
DEPTH GAUGE X0809708 W/2MM BALL TIP
MEDTRONIC SOFAMOR DANEK, INC.
X0809708
In Commercial Distribution

  • 00613994839862 ()


  • Orthopaedic bone calliper
CURETTE EX0410404 BAYONETED R STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0410404
In Commercial Distribution

  • 00613994839169 ()


  • Bone curette, reusable
CURETTE EX0410403 BAYONETED R ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0410403
In Commercial Distribution

  • 00613994839152 ()


  • Bone curette, reusable
CURETTE EX0410402 BAYONETED L ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0410402
In Commercial Distribution

  • 00613994839145 ()


  • Bone curette, reusable
DRIVER EX0610183 3.5MM CAPTIVE TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0610183
In Commercial Distribution

  • 00613994839138 ()


  • Orthopaedic implant driver
KERRISON EX0610124 BAYONETED 4MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0610124
In Commercial Distribution

  • 00613994839121 ()


  • Bone curette, reusable
KERRISON EX0610122 BAYONETED 2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0610122
In Commercial Distribution

  • 00613994839107 ()


  • Bone curette, reusable
BLADE X0610263 FIXED DISCECTOMY 25MM
MEDTRONIC SOFAMOR DANEK, INC.
X0610263
In Commercial Distribution

  • 00613994838872 ()


  • Orthopaedic knife
BLADE X0610265 FIXED DISCECTOMY 35MM
MEDTRONIC SOFAMOR DANEK, INC.
X0610265
In Commercial Distribution

  • 00613994838858 ()


  • Orthopaedic knife
BLADE X0610270 FIXED DISCECTOMY 60MM
MEDTRONIC SOFAMOR DANEK, INC.
X0610270
In Commercial Distribution

  • 00613994838803 ()


  • Orthopaedic knife
BLADE X0610272 FIXED DISCECTOMY 70MM
MEDTRONIC SOFAMOR DANEK, INC.
X0610272
In Commercial Distribution

  • 00613994838780 ()


  • Orthopaedic knife
BLADE X0610273 FIXED DISCECTOMY 75MM
MEDTRONIC SOFAMOR DANEK, INC.
X0610273
In Commercial Distribution

  • 00613994838773 ()


  • Orthopaedic knife
STRAIGHT PROBE X0510076 QC BAYONET
MEDTRONIC SOFAMOR DANEK, INC.
X0510076
In Commercial Distribution

  • 00613994838759 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
COMPRESS DISTRACT EX0610139 LONG, BOTT
MEDTRONIC SOFAMOR DANEK, INC.
EX0610139
In Commercial Distribution

  • 00613994838179 ()


  • Orthopaedic surgical distractor, internal
COMPRESS DISTRACT EX0610138 LONG, TOP
MEDTRONIC SOFAMOR DANEK, INC.
EX0610138
In Commercial Distribution

  • 00613994838162 ()


  • Orthopaedic surgical distractor, internal
SLEEVE X1006153 CAP RETENTION
MEDTRONIC SOFAMOR DANEK, INC.
X1006153
In Commercial Distribution

  • 00613994352750 ()


  • Orthopaedic implantation sleeve, reusable
TRIAL 2986855 8MM X 55MM
MEDTRONIC SOFAMOR DANEK, INC.
2986855
In Commercial Distribution

  • 00613994352408 ()

  • Outer Diameter: 8.0 Millimeter
  • Length: 55.0 Millimeter


  • Spinal implant trial
TRIAL 2986850 8MM X 50MM
MEDTRONIC SOFAMOR DANEK, INC.
2986850
In Commercial Distribution

  • 00613994352392 ()

  • Length: 50.0 Millimeter
  • Outer Diameter: 8.0 Millimeter


  • Spinal implant trial
TRIAL 2986845 8MM X 45MM
MEDTRONIC SOFAMOR DANEK, INC.
2986845
In Commercial Distribution

  • 00613994352385 ()

  • Length: 45.0 Millimeter
  • Outer Diameter: 8.0 Millimeter


  • Spinal implant trial
SCREW DRIVER 1204444 QUAD Peek Prevail
MEDTRONIC SOFAMOR DANEK, INC.
1204444
In Commercial Distribution

  • 00613994351128 ()


  • Surgical screwdriver, reusable
TAMP 9359003 SMALL BONE TAMP
MEDTRONIC SOFAMOR DANEK, INC.
9359003
In Commercial Distribution

  • 00613994338167 ()


  • Surgical tamp, reusable
TIP X0307351 BONE HARVESTER
MEDTRONIC SOFAMOR DANEK, INC.
X0307351
In Commercial Distribution

  • 00613994326065 ()


  • Orthopaedic surgical distractor, internal
LID 7574000L INSTR CASE LID TRIPLE
MEDTRONIC SOFAMOR DANEK, INC.
7574000L
In Commercial Distribution

  • 00613994325396 ()


  • Instrument tray, reusable
AWL 7967003 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
7967003
In Commercial Distribution

  • 00613994321213 ()


  • Bone awl, reusable
AWL 7967020 FIXED ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
7967020
In Commercial Distribution

  • 00613994320872 ()


  • Bone awl, reusable
KERRISON X0207014 4MM 40 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0207014
In Commercial Distribution

  • 00613994316936 ()


  • Bone curette, reusable
KERRISON X0207012 2MM 40 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0207012
In Commercial Distribution

  • 00613994316929 ()


  • Bone curette, reusable
KERRISON X0207011 1MM 40 DEG
MEDTRONIC SOFAMOR DANEK, INC.
X0207011
In Commercial Distribution

  • 00613994316912 ()


  • Bone curette, reusable
INSTRUMENT 778000010 ANGL OSTEOTOME 5.5
MEDTRONIC SOFAMOR DANEK, INC.
778000010
In Commercial Distribution

  • 00613994313164 ()


  • Orthopaedic osteotome
INSTRUMENT 778000019 ANGL OSTEOTOME 6.35
MEDTRONIC SOFAMOR DANEK, INC.
778000019
In Commercial Distribution

  • 00613994312990 ()


  • Orthopaedic osteotome
lNSTRUMENT 778000018 STRT OSTEOTOME 6.35
MEDTRONIC SOFAMOR DANEK, INC.
778000018
In Commercial Distribution

  • 00613994312983 ()


  • Orthopaedic osteotome
TOOL 1201111 STND ALONE REV PEEK PREVAIL
MEDTRONIC SOFAMOR DANEK, INC.
1201111
In Commercial Distribution

  • 00613994309495 ()


  • Surgical screwdriver, reusable
INSERTER 1220222 SHAFT PEEK Prevail
MEDTRONIC SOFAMOR DANEK, INC.
1220222
In Commercial Distribution

  • 00613994309488 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
POPPER 7971001 SMALL
MEDTRONIC SOFAMOR DANEK, INC.
7971001
In Commercial Distribution

  • 00613994309266 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER 8675203 5MM HEX
MEDTRONIC SOFAMOR DANEK, INC.
8675203
In Commercial Distribution

  • 00613994306265 ()


  • Surgical screwdriver, reusable
DRIVER 8675207 LONG
MEDTRONIC SOFAMOR DANEK, INC.
8675207
In Commercial Distribution

  • 00613994306227 ()


  • Surgical screwdriver, reusable
DISTRACTOR 7570932 REDUX
MEDTRONIC SOFAMOR DANEK, INC.
7570932
In Commercial Distribution

  • 00613994302786 ()


  • Orthopaedic surgical distractor, internal
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