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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300SS UNIVERSAL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0103011
In Commercial Distribution

  • 00721902725418 ()


  • Surgical instrument handle, non-torque-limiting
ZEP DRILL BIT-TRI FLAT-300SS
MEDTRONIC SOFAMOR DANEK, INC.
X0103009
In Commercial Distribution

  • 00721902725395 ()


  • Fluted surgical drill bit, reusable
ZEP MONO D GUIDE-NO LEG-300SS
MEDTRONIC SOFAMOR DANEK, INC.
X0103008
In Commercial Distribution

  • 00721902725388 ()


  • General internal orthopaedic fixation system implantation kit
ZEP MONO DRILL GUIDE-300SS
MEDTRONIC SOFAMOR DANEK, INC.
X0103007
In Commercial Distribution

  • 00721902725364 ()


  • Fluted surgical drill bit, reusable
ZEP DUAL DRILL GUIDE-300SS
MEDTRONIC SOFAMOR DANEK, INC.
X0103006
In Commercial Distribution

  • 00721902725357 ()


  • Fluted surgical drill bit, reusable
GOLD HANDLE PROBE
MEDTRONIC SOFAMOR DANEK, INC.
X1102050
In Commercial Distribution

  • 00721902723544 ()


  • Surgical instrument handle, non-torque-limiting
INSERTER 2900601 HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
2900601
In Commercial Distribution

  • 00721902715440 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
6.5MM T-HANDLE TAP
MEDTRONIC SOFAMOR DANEK, INC.
X1202010
In Commercial Distribution

  • 00721902714108 ()


  • Bone tap, reusable
5.5MM T-HANDLE TAP
MEDTRONIC SOFAMOR DANEK, INC.
X1202009
In Commercial Distribution

  • 00721902714061 ()


  • Bone tap, reusable
ATL PLATE BENDER SINGLE LEVEL
MEDTRONIC SOFAMOR DANEK, INC.
X1202099
In Commercial Distribution

  • 00721902713910 ()


  • Manual orthopaedic bender, reusable
GAINES COMPRESSOR
MEDTRONIC SOFAMOR DANEK, INC.
X1202007
In Commercial Distribution

  • 00721902711237 ()


  • Orthopaedic surgical distractor, internal
M8 MAS DRIVER WITH PIN
MEDTRONIC SOFAMOR DANEK, INC.
X1202005
In Commercial Distribution

  • 00721902711183 ()


  • Orthopaedic implant driver
FRENCH BENDER, 3 WHEELS
MEDTRONIC SOFAMOR DANEK, INC.
X1002999
In Commercial Distribution

  • 00721902710926 ()


  • Manual orthopaedic bender, reusable
EXTRAS SET-FULL SIZE PIN MAT
MEDTRONIC SOFAMOR DANEK, INC.
1850073
In Commercial Distribution

  • 00721902710001 ()


  • Instrument tray, reusable
VX AWL-2.25MM-5MMSTOP
MEDTRONIC SOFAMOR DANEK, INC.
X0103003
In Commercial Distribution

  • 00721902709432 ()


  • Bone awl, reusable
INSTRUMENT 9339075 GAGE
MEDTRONIC SOFAMOR DANEK, INC.
9339075
In Commercial Distribution

  • 00721902708800 ()


  • Surgical depth gauge, reusable
SHORT FINAL PLUG TIGHTENER
MEDTRONIC SOFAMOR DANEK, INC.
X0103004
In Commercial Distribution

  • 00721902697500 ()


  • Surgical screwdriver, reusable
QUICK CONNECT T20 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0103001
In Commercial Distribution

  • 00721902696831 ()


  • Orthopaedic implant driver
INSTRUMENT 9339005 PLTE PRSDR COUNT TORQ
MEDTRONIC SOFAMOR DANEK, INC.
9339005
In Commercial Distribution

  • 00721902692956 ()


  • Orthopaedic counter-torque/rod-pushing instrument
INSTRUMENT 9339096 AWL QUICK ECT
MEDTRONIC SOFAMOR DANEK, INC.
9339096
In Commercial Distribution

  • 00721902692734 ()


  • Bone awl, reusable
INSTRUMENT 9339041 TORQ LIMIT NUT DRVR
MEDTRONIC SOFAMOR DANEK, INC.
9339041
In Commercial Distribution

  • 00721902692659 ()


  • Surgical drill guide, reusable
INSTRUMENT 9339031 HEX DRIVER QC
MEDTRONIC SOFAMOR DANEK, INC.
9339031
In Commercial Distribution

  • 00721902692598 ()


  • Surgical drill guide, reusable
INSTRUMENT 9339021 FIXED DRILL
MEDTRONIC SOFAMOR DANEK, INC.
9339021
In Commercial Distribution

  • 00721902692581 ()


  • Surgical drill guide, reusable
INSTRUMENT 9339010 MODULAR DRILL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
9339010
In Commercial Distribution

  • 00721902692574 ()


  • Surgical drill guide, reusable
MOD TAYLOR SPINAL RETRACTO
MEDTRONIC SOFAMOR DANEK, INC.
X8369001
In Commercial Distribution

  • 00721902684173 ()


  • Surgical retractor/retraction system blade, reusable
M8 MAS HEAD POSITIONER
MEDTRONIC SOFAMOR DANEK, INC.
X1202001
In Commercial Distribution

  • 00721902683978 ()


  • Orthopaedic fixation implant alignment tool
TAPERED PEDICLE MARKER, RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X1102022
In Commercial Distribution

  • 00721902683688 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
TAPERED PEDICLE MARKER, LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X1102021
In Commercial Distribution

  • 00721902683619 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
3.0MM EGG HANDLE AWL
MEDTRONIC SOFAMOR DANEK, INC.
X1102017
In Commercial Distribution

  • 00721902683480 ()


  • Bone awl, reusable
PLATE PERSUADER
MEDTRONIC SOFAMOR DANEK, INC.
Y9339005
In Commercial Distribution

  • 00721902683350 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
SCREWDRIVER
MEDTRONIC SOFAMOR DANEK, INC.
Y853-630
In Commercial Distribution

  • 00721902683268 ()


  • Surgical screwdriver, reusable
MOD. WORKING CHANNEL
MEDTRONIC SOFAMOR DANEK, INC.
X1002026
In Commercial Distribution

  • 00721902677595 ()


  • Orthopaedic rod reducer
SHAVER YIB0802-023 DISC 15MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-023
In Commercial Distribution

  • 00721902674914 ()


  • Orthopaedic knife
SHAVER YIB0802-022 DISC 14MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-022
In Commercial Distribution

  • 00721902674907 ()


  • Orthopaedic knife
SHAVER YIB0802-021 DISC 13MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-021
In Commercial Distribution

  • 00721902674891 ()


  • Orthopaedic knife
SHAVER YIB0802-020 DISC 12MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-020
In Commercial Distribution

  • 00721902674884 ()


  • Orthopaedic knife
SHAVER YIB0802-019 DISC 11MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-019
In Commercial Distribution

  • 00721902674877 ()


  • Orthopaedic knife
SHAVER YIB0802-018 DISC 10MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-018
In Commercial Distribution

  • 00721902674860 ()


  • Orthopaedic knife
SHAVER YIB0802-017 DISC 9MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-017
In Commercial Distribution

  • 00721902674839 ()


  • Orthopaedic knife
SHAVER YIB0802-016 DISC 8MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-016
In Commercial Distribution

  • 00721902674822 ()


  • Orthopaedic knife
SHAVER YIB0802-015 DISC 7MM
MEDTRONIC SOFAMOR DANEK, INC.
YIB0802-015
In Commercial Distribution

  • 00721902674815 ()


  • Orthopaedic knife
75MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002375
In Commercial Distribution

  • 00721902651199 ()


  • Orthopaedic knife
70MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002370
In Commercial Distribution

  • 00721902651182 ()


  • Orthopaedic knife
65MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002365
In Commercial Distribution

  • 00721902651175 ()


  • Orthopaedic knife
60MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002360
In Commercial Distribution

  • 00721902651144 ()


  • Orthopaedic knife
55MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002355
In Commercial Distribution

  • 00721902651137 ()


  • Orthopaedic knife
50MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002350
In Commercial Distribution

  • 00721902651120 ()


  • Orthopaedic knife
45MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002345
In Commercial Distribution

  • 00721902651113 ()


  • Orthopaedic knife
40MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002340
In Commercial Distribution

  • 00721902651106 ()


  • Orthopaedic knife
35MM TAPERED DISC. BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1002335
In Commercial Distribution

  • 00721902650956 ()


  • Orthopaedic knife
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