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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3.5MM CORTICAL BONE TAP
MEDTRONIC SOFAMOR DANEK, INC.
X0395-011
In Commercial Distribution

  • 00673978135021 ()


  • Bone tap, reusable
PENNFIELD ELEVATOR - MEDIUM
MEDTRONIC SOFAMOR DANEK, INC.
X0395-009
In Commercial Distribution

  • 00673978135007 ()


  • Bone lever/elevator, reusable
PENNFIELD ELEVATOR - SMALL
MEDTRONIC SOFAMOR DANEK, INC.
X0395-008
In Commercial Distribution

  • 00673978134994 ()


  • Bone lever/elevator, reusable
PENNFIELD ELEVATOR - LARGE
MEDTRONIC SOFAMOR DANEK, INC.
X0395-007
In Commercial Distribution

  • 00673978134987 ()


  • Bone lever/elevator, reusable
OFFSET COBB ELEVATOR
MEDTRONIC SOFAMOR DANEK, INC.
X0395-006
In Commercial Distribution

  • 00673978134970 ()


  • Bone lever/elevator, reusable
THREADED AWL
MEDTRONIC SOFAMOR DANEK, INC.
X0394-003
In Commercial Distribution

  • 00673978134345 ()


  • Bone awl, reusable
TRIMLINE 14 X 50 WITH TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X0299-064
In Commercial Distribution

  • 00673978133973 ()


  • Orthopaedic knife
TRIMLINE, 14 X 40 WITH TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X0299-063
In Commercial Distribution

  • 00673978133966 ()


  • Orthopaedic knife
TRIMLINE RETRACTOR FRAME L
MEDTRONIC SOFAMOR DANEK, INC.
X0299-036
In Commercial Distribution

  • 00673978133706 ()


  • Surgical retraction system, reusable
TRIMLINE RETRACTOR FRAME LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0299-035
In Commercial Distribution

  • 00673978133690 ()


  • Surgical retraction system, reusable
TISSUE RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0299-007
In Commercial Distribution

  • 00673978133454 ()


  • Surgical retractor/retraction system blade, reusable
MODIFIED ADSON RETRACTORS
MEDTRONIC SOFAMOR DANEK, INC.
X0298-042
In Commercial Distribution

  • 00673978133188 ()


  • Surgical retractor/retraction system blade, reusable
5MM, 6 DEG. ANGLED IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0298-026
In Commercial Distribution

  • 00673978133058 ()


  • Orthopaedic implant impactor, reusable
5MM STRAIGHT IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0298-025
In Commercial Distribution

  • 00673978133041 ()


  • Orthopaedic implant impactor, reusable
L-BENDER, 6.35 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0298-024
In Commercial Distribution

  • 00673978133034 ()


  • Manual orthopaedic bender, reusable
L-BENDER, 6.35 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0298-023
In Commercial Distribution

  • 00673978133027 ()


  • Manual orthopaedic bender, reusable
L-BENDER, 5.5 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0298-022
In Commercial Distribution

  • 00673978133010 ()


  • Manual orthopaedic bender, reusable
L-BENDER, 5.5 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
X0298-021
In Commercial Distribution

  • 00673978133003 ()


  • Manual orthopaedic bender, reusable
ANT RING CURETTE, 4MM STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0298-017
In Commercial Distribution

  • 00673978132969 ()


  • Bone curette, reusable
MODIFIED ROD REDUCER BODY
MEDTRONIC SOFAMOR DANEK, INC.
X0297-013
In Commercial Distribution

  • 00673978132761 ()


  • Orthopaedic rod reducer
UCSS NON CANN 4.0 DRILL BIT
MEDTRONIC SOFAMOR DANEK, INC.
X0297-010
In Commercial Distribution

  • 00673978132754 ()


  • Fluted surgical drill bit, reusable
ORION SD W/SPRING LDED RET SLV
MEDTRONIC SOFAMOR DANEK, INC.
X0296-031
In Commercial Distribution

  • 00673978132624 ()


  • Orthopaedic implantation sleeve, reusable
AXIS SCREWDRIVER X0295-023 11 INCH LONG
MEDTRONIC SOFAMOR DANEK, INC.
X0295-023
In Commercial Distribution

  • 00673978132280 ()


  • Orthopaedic implant driver
T-HANDLE EXT LENGTH HEX DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0199-038
In Commercial Distribution

  • 00673978131788 ()


  • Orthopaedic implant driver
COUNTER TORQUE EXT. WRENCH
MEDTRONIC SOFAMOR DANEK, INC.
X0199-037
In Commercial Distribution

  • 00673978131771 ()


  • Surgical torque wrench, reusable
TRIMLINE, 14 X 60 W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X0199-027
In Commercial Distribution

  • 00673978131672 ()


  • Surgical retraction system, reusable
TRIMLINE, 14 X 55 W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X0199-026
In Commercial Distribution

  • 00673978131665 ()


  • Surgical retraction system, reusable
TRIMLINE, 14 X 45 W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X0199-025
In Commercial Distribution

  • 00673978131658 ()


  • Surgical retraction system, reusable
TRIMLINE, 14 X 35 W/TEETH
MEDTRONIC SOFAMOR DANEK, INC.
X0199-024
In Commercial Distribution

  • 00673978131641 ()


  • Surgical retraction system, reusable
SELF LIMITING T HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X0199-018
In Commercial Distribution

  • 00673978131580 ()


  • Surgical instrument handle, torque-limiting
CDH T-HANDLE T20 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0199-016
In Commercial Distribution

  • 00673978131566 ()


  • Orthopaedic implant driver
CDH T-HANDLE PROV PLUG DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0199-015
In Commercial Distribution

  • 00673978131559 ()


  • Orthopaedic implant driver
38MM BONE HARVESTER
MEDTRONIC SOFAMOR DANEK, INC.
X0199-014
In Commercial Distribution

  • 00673978131542 ()


  • Bone trephine, reusable
GRATER/REAMER SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0199-013
In Commercial Distribution

  • 00673978131535 ()


  • Orthopaedic broach
MODIFIED GUIDE TUBE, 14 X 7MM
MEDTRONIC SOFAMOR DANEK, INC.
X0199-010
In Commercial Distribution

  • 00673978131504 ()


  • General internal orthopaedic fixation system implantation kit
MODIFIED GUIDE TUBE, 14 X 6MM
MEDTRONIC SOFAMOR DANEK, INC.
X0199-009
In Commercial Distribution

  • 00673978131498 ()


  • General internal orthopaedic fixation system implantation kit
MODIFIED GUIDE TUBE, 14 X 5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0199-008
In Commercial Distribution

  • 00673978131481 ()


  • General internal orthopaedic fixation system implantation kit
MODIFIED GUIDE TUBE, 12 X 7MM
MEDTRONIC SOFAMOR DANEK, INC.
X0199-007
In Commercial Distribution

  • 00673978131474 ()


  • General internal orthopaedic fixation system implantation kit
MODIFIED GUIDE TUBE, 12 X 6MM
MEDTRONIC SOFAMOR DANEK, INC.
X0199-006
In Commercial Distribution

  • 00673978131467 ()


  • General internal orthopaedic fixation system implantation kit
MODIFIED GUIDE TUBE, 12 X 5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0199-005
In Commercial Distribution

  • 00673978131450 ()


  • General internal orthopaedic fixation system implantation kit
TRIMLINE CERVICAL BLDE 77X38.5
MEDTRONIC SOFAMOR DANEK, INC.
X0199-004
In Commercial Distribution

  • 00673978131443 ()


  • Surgical retractor/retraction system blade, reusable
TRIMLINE CERVICAL BLDE 77X30
MEDTRONIC SOFAMOR DANEK, INC.
X0199-003
In Commercial Distribution

  • 00673978131436 ()


  • Surgical retractor/retraction system blade, reusable
TRIMLINE CERVICAL BLDE 67X38.5
MEDTRONIC SOFAMOR DANEK, INC.
X0199-002
In Commercial Distribution

  • 00673978131429 ()


  • Surgical retractor/retraction system blade, reusable
6.35MM KNURLED ROD GRIPPER
MEDTRONIC SOFAMOR DANEK, INC.
X0198-021
In Commercial Distribution

  • 00673978131269 ()


  • Surgical flat-nosed pliers
MED ANGLED MESH IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0198-020
In Commercial Distribution

  • 00673978131252 ()


  • Orthopaedic implant impactor, reusable
MED STRAIGHT MESH IMPACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0198-019
In Commercial Distribution

  • 00673978131245 ()


  • Orthopaedic implant impactor, reusable
13MM DRILL BIT W/ KNURL GRIP
MEDTRONIC SOFAMOR DANEK, INC.
X0198-009
In Commercial Distribution

  • 00673978131146 ()


  • Fluted surgical drill bit, reusable
40MM RASP, 10 X 14MM
MEDTRONIC SOFAMOR DANEK, INC.
X0198-008
In Commercial Distribution

  • 00673978131139 ()


  • Bone file/rasp, manual, reusable
40MM RASP, 10 X 12MM
MEDTRONIC SOFAMOR DANEK, INC.
X0198-007
In Commercial Distribution

  • 00673978131122 ()


  • Bone file/rasp, manual, reusable
40MM RASP, 10 X 10MM
MEDTRONIC SOFAMOR DANEK, INC.
X0198-006
In Commercial Distribution

  • 00673978131115 ()


  • Bone file/rasp, manual, reusable
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