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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TAP EX0913095 7.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0913095
In Commercial Distribution

  • 00643169431942 ()


  • Bone tap, reusable
TAP EX0913094 6.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0913094
In Commercial Distribution

  • 00643169431935 ()


  • Bone tap, reusable
TAP EX0913093 5.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0913093
In Commercial Distribution

  • 00643169431928 ()


  • Bone tap, reusable
TAP EX0913092 4.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0913092
In Commercial Distribution

  • 00643169431911 ()


  • Bone tap, reusable
BLADE EX1013241 3CM NARROW M/L
MEDTRONIC SOFAMOR DANEK, INC.
EX1013241
In Commercial Distribution

  • 00643169431072 ()


  • Surgical retraction system, reusable
BLADE EX1013240 3CM WIDE M/L
MEDTRONIC SOFAMOR DANEK, INC.
EX1013240
In Commercial Distribution

  • 00643169431065 ()


  • Surgical retraction system, reusable
DISTRACTOR EX0613045 VARIABLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0613045
Not in Commercial Distribution

  • 00643169429147 ()


  • Orthopaedic surgical distractor, internal
COBB EX06131005 ELEVATOR STR SMALL 25.4
MEDTRONIC SOFAMOR DANEK, INC.
EX06131005
In Commercial Distribution

  • 00643169420199 ()


  • Bone lever/elevator, reusable
PROBE EX1013017 SPHERE MARKER
MEDTRONIC SOFAMOR DANEK, INC.
EX1013017
In Commercial Distribution

  • 00643169420175 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE EX1013016 CYLINDER MARKER
MEDTRONIC SOFAMOR DANEK, INC.
EX1013016
In Commercial Distribution

  • 00643169420168 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
SCREWDRIVER X0313269
MEDTRONIC SOFAMOR DANEK, INC.
X0313269
In Commercial Distribution

  • 00643169417434 ()


  • Orthopaedic implant driver
DTS GUIDE EX0813076 SNGL BARREL VARIABLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0813076
In Commercial Distribution

  • 00643169415898 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX0514021 TAPERED HEX 3.2MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0514021
In Commercial Distribution

  • 00643169523562 ()


  • Orthopaedic implant driver
RETRACTOR EX0614038 PADDLE NERVE ROOT
MEDTRONIC SOFAMOR DANEK, INC.
EX0614038
Not in Commercial Distribution

  • 00643169523500 ()


  • Surgical retractor/retraction system blade, reusable
DRIVER EX0614091 T-25 330 LG SLR HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0614091
Not in Commercial Distribution

  • 00643169513792 ()


  • Orthopaedic implant driver
AWL X0614039 FIXED ANGLE
MEDTRONIC SOFAMOR DANEK, INC.
X0614039
In Commercial Distribution

  • 00643169511644 ()


  • Bone awl, reusable
TAP EX0811242 3.5 X 13MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0811242
In Commercial Distribution

  • 00643169064270 ()


  • Bone tap, reusable
DISTRACTOR X0310708 RATCHETING
MEDTRONIC SOFAMOR DANEK, INC.
X0310708
Not in Commercial Distribution

  • 00643169064263 ()


  • Orthopaedic surgical distractor, internal
PROBE X0310688 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0310688
In Commercial Distribution

  • 00643169064256 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE X0310686 CURVED
MEDTRONIC SOFAMOR DANEK, INC.
X0310686
In Commercial Distribution

  • 00643169064249 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
RASP X0310680 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0310680
In Commercial Distribution

  • 00643169064232 ()


  • Bone file/rasp, manual, reusable
RASP X0310679 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0310679
In Commercial Distribution

  • 00643169064225 ()


  • Bone file/rasp, manual, reusable
RASP X0310678 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0310678
In Commercial Distribution

  • 00643169064218 ()


  • Bone file/rasp, manual, reusable
PLASTIC SLEEVE X0811534 FOR 5.5 & 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X0811534
In Commercial Distribution

  • 00643169064201 ()


  • Orthopaedic implantation sleeve, reusable
METAL SLEEVE X0811533 FOR 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X0811533
In Commercial Distribution

  • 00643169064195 ()


  • Orthopaedic implantation sleeve, reusable
SCREWDRIVER X0811532 FOR 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X0811532
In Commercial Distribution

  • 00643169064188 ()


  • Surgical screwdriver, reusable
METAL SLEEVE X0811530 FOR 5.5 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X0811530
In Commercial Distribution

  • 00643169064171 ()


  • Orthopaedic implantation sleeve, reusable
SCREWDRIVER X0811529 FOR 5.5 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X0811529
In Commercial Distribution

  • 00643169064164 ()


  • Surgical screwdriver, reusable
TROCAR EX0711447 PEDICLE TROCAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0711447
In Commercial Distribution

  • 00643169063990 ()


  • Orthopaedic trocar blade, reusable
AWL EX0711448 PEDICLE AWL
MEDTRONIC SOFAMOR DANEK, INC.
EX0711448
In Commercial Distribution

  • 00643169063983 ()


  • Bone awl, reusable
COUNTER TORQUE EX0711455 4.75
MEDTRONIC SOFAMOR DANEK, INC.
EX0711455
In Commercial Distribution

  • 00643169062122 ()


  • Orthopaedic counter-torque/rod-pushing instrument
GUIDE EX0811459 FIXED DRILL
MEDTRONIC SOFAMOR DANEK, INC.
EX0811459
In Commercial Distribution

  • 00643169061996 ()


  • Surgical drill guide, reusable
AWL EX0811458 FIXED RETRACTABLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0811458
In Commercial Distribution

  • 00643169061989 ()


  • Bone awl, reusable
RETRACTOR EX0711497 NERVE
MEDTRONIC SOFAMOR DANEK, INC.
EX0711497
In Commercial Distribution

  • 00643169061811 ()


  • Surgical retractor/retraction system blade, reusable
DRIVER EX0811450 5.5 MAS W/CROSSBAR
MEDTRONIC SOFAMOR DANEK, INC.
EX0811450
In Commercial Distribution

  • 00643169061798 ()


  • Orthopaedic implant driver
DRIVER EX0811294 ASSY 5.5 MAS WELDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0811294
In Commercial Distribution

  • 00643169061781 ()


  • Orthopaedic implant driver
OSTEOTOME EX0811303 8MM CUTTING
MEDTRONIC SOFAMOR DANEK, INC.
EX0811303
In Commercial Distribution

  • 00643169061750 ()


  • Orthopaedic osteotome
PIN RECEPTACLE EX0711503 DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
EX0711503
In Commercial Distribution

  • 00643169061682 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR EX0711502 CERVICAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0711502
In Commercial Distribution

  • 00643169061675 ()


  • Orthopaedic surgical distractor, internal
TAP X0711580 3.5MM TAPERED SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0711580
In Commercial Distribution

  • 00643169060760 ()


  • Bone tap, reusable
RASP X0811307 4MM ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X0811307
In Commercial Distribution

  • 00643169060753 ()


  • Bone file/rasp, manual, reusable
RASP X0811306 3MM ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X0811306
In Commercial Distribution

  • 00643169060746 ()


  • Bone file/rasp, manual, reusable
RASP X0811305 2MM ANGLEG
MEDTRONIC SOFAMOR DANEK, INC.
X0811305
In Commercial Distribution

  • 00643169060739 ()


  • Bone file/rasp, manual, reusable
ELEVATOR X0811304 FACET FREER
MEDTRONIC SOFAMOR DANEK, INC.
X0811304
In Commercial Distribution

  • 00643169060722 ()


  • Bone lever/elevator, reusable
DRIVER X0811006 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X0811006
In Commercial Distribution

  • 00643169060715 ()


  • Surgical screwdriver, reusable
DISTRACTOR EX0711577 BAYONETTED
MEDTRONIC SOFAMOR DANEK, INC.
EX0711577
In Commercial Distribution

  • 00643169060579 ()


  • Orthopaedic surgical distractor, internal
TREPHINE X0811126 3.6MM
MEDTRONIC SOFAMOR DANEK, INC.
X0811126
In Commercial Distribution

  • 00643169060272 ()


  • Bone trephine, reusable
DISTRACTOR X0811234 SHAFT 18MM STD-TYPE
MEDTRONIC SOFAMOR DANEK, INC.
X0811234
In Commercial Distribution

  • 00643169060005 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0811233 SHAFT 16MM STD-TYPE
MEDTRONIC SOFAMOR DANEK, INC.
X0811233
In Commercial Distribution

  • 00643169059993 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0811232 TIP 10X20 MODIFIED
MEDTRONIC SOFAMOR DANEK, INC.
X0811232
In Commercial Distribution

  • 00643169059986 ()


  • Orthopaedic surgical distractor, internal
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