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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BONE REAMER EX0411430 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0411430
In Commercial Distribution

  • 00643169000209 ()


  • Orthopaedic broach
RASP EX0411059 LARGE 16MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411059
In Commercial Distribution

  • 00643169006652 ()


  • Bone file/rasp, manual, reusable
RASP EX0411058 LARGE 14MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411058
In Commercial Distribution

  • 00643169006645 ()


  • Bone file/rasp, manual, reusable
RASP EX0411057 LARGE 12MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411057
In Commercial Distribution

  • 00643169006638 ()


  • Bone file/rasp, manual, reusable
RASP EX0411056 LARGE 10MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411056
In Commercial Distribution

  • 00643169006621 ()


  • Bone file/rasp, manual, reusable
BROACH EX0411328 18MM FIXED
MEDTRONIC SOFAMOR DANEK, INC.
EX0411328
In Commercial Distribution

  • 00643169005921 ()


  • Orthopaedic broach
BROACH EX0411327 16MM FIXED
MEDTRONIC SOFAMOR DANEK, INC.
EX0411327
In Commercial Distribution

  • 00643169005914 ()


  • Orthopaedic broach
BROACH EX0411326 14MM FIXED
MEDTRONIC SOFAMOR DANEK, INC.
EX0411326
In Commercial Distribution

  • 00643169005907 ()


  • Orthopaedic broach
BROACH EX0411325 12MM FIXED
MEDTRONIC SOFAMOR DANEK, INC.
EX0411325
In Commercial Distribution

  • 00643169005891 ()


  • Orthopaedic broach
BROACH EX0411324 10MM FIXED
MEDTRONIC SOFAMOR DANEK, INC.
EX0411324
In Commercial Distribution

  • 00643169005884 ()


  • Orthopaedic broach
BROACH EX0411323 8MM FIXED
MEDTRONIC SOFAMOR DANEK, INC.
EX0411323
In Commercial Distribution

  • 00643169005877 ()


  • Orthopaedic broach
BENDER EX1210031 L.P. IN-SITU 4.75 RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210031
In Commercial Distribution

  • 00643169005846 ()


  • Manual orthopaedic bender, reusable
BENDER EX1210030 L.P. IN-SITU 4.75 LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX1210030
In Commercial Distribution

  • 00643169005839 ()


  • Manual orthopaedic bender, reusable
RASP EX0311007 STRAIGHT CONVEX
MEDTRONIC SOFAMOR DANEK, INC.
EX0311007
In Commercial Distribution

  • 00643169003019 ()


  • Bone file/rasp, manual, reusable
RASP EX0411050 SMALL 10MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411050
In Commercial Distribution

  • 00643169006805 ()


  • Bone file/rasp, manual, reusable
RASP EX0411049 SMALL 20MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411049
In Commercial Distribution

  • 00643169006799 ()


  • Bone file/rasp, manual, reusable
RASP EX0411048 SMALL 18MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411048
In Commercial Distribution

  • 00643169006782 ()


  • Bone file/rasp, manual, reusable
RASP EX0411047 SMALL 16MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411047
In Commercial Distribution

  • 00643169006775 ()


  • Bone file/rasp, manual, reusable
RASP EX0411046 SMALL 14MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411046
In Commercial Distribution

  • 00643169006768 ()


  • Bone file/rasp, manual, reusable
RASP EX0411045 SMALL 12MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411045
In Commercial Distribution

  • 00643169006751 ()


  • Bone file/rasp, manual, reusable
RASP EX0411044 SMALL 10MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411044
In Commercial Distribution

  • 00643169006744 ()


  • Bone file/rasp, manual, reusable
RASP EX0411067 LARGE 20MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411067
In Commercial Distribution

  • 00643169006737 ()


  • Bone file/rasp, manual, reusable
RASP EX0411066 LARGE 18MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411066
In Commercial Distribution

  • 00643169006720 ()


  • Bone file/rasp, manual, reusable
RASP EX0411065 LARGE 16MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411065
In Commercial Distribution

  • 00643169006713 ()


  • Bone file/rasp, manual, reusable
RASP EX0411064 LARGE 14MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411064
In Commercial Distribution

  • 00643169006706 ()


  • Bone file/rasp, manual, reusable
RASP EX0411063 LARGE 12MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411063
In Commercial Distribution

  • 00643169006690 ()


  • Bone file/rasp, manual, reusable
RASP EX0411062 LARGE 10MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411062
In Commercial Distribution

  • 00643169006683 ()


  • Bone file/rasp, manual, reusable
RASP EX0411061 LARGE 20MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411061
In Commercial Distribution

  • 00643169006676 ()


  • Bone file/rasp, manual, reusable
RASP EX0411060 LARGE 18MM / 12 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411060
In Commercial Distribution

  • 00643169006669 ()


  • Bone file/rasp, manual, reusable
RASP EX0411055 SMALL 20MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411055
In Commercial Distribution

  • 00643169006850 ()


  • Bone file/rasp, manual, reusable
RASP EX0411054 SMALL 18MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411054
In Commercial Distribution

  • 00643169006843 ()


  • Bone file/rasp, manual, reusable
RASP EX0411053 SMALL 16MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411053
In Commercial Distribution

  • 00643169006836 ()


  • Bone file/rasp, manual, reusable
RASP EX0411052 SMALL 14MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411052
In Commercial Distribution

  • 00643169006829 ()


  • Bone file/rasp, manual, reusable
RASP EX0411051 SMALL 12MM / 8 DEG
MEDTRONIC SOFAMOR DANEK, INC.
EX0411051
In Commercial Distribution

  • 00643169006812 ()


  • Bone file/rasp, manual, reusable
CURETTE EX0210156 NON-BAYONETED L ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0210156
In Commercial Distribution

  • 00613994764409 ()


  • Bone curette, reusable
CURETTE EX0210155 NON-BAYONETED R ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
EX0210155
In Commercial Distribution

  • 00613994764393 ()


  • Bone curette, reusable
CURETTE EX0210154 NON-BAYONETED STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0210154
In Commercial Distribution

  • 00613994764386 ()


  • Bone curette, reusable
BENDER 5484313 INSITU - LEFT 4.75
MEDTRONIC SOFAMOR DANEK, INC.
5484313
In Commercial Distribution

  • 00613994761576 ()


  • Manual orthopaedic bender, reusable
BENDER 5484316 CORONAL - RIGHT 4.75
MEDTRONIC SOFAMOR DANEK, INC.
5484316
In Commercial Distribution

  • 00613994761538 ()


  • Manual orthopaedic bender, reusable
BENDER 5484315 CORONAL - LEFT 4.75
MEDTRONIC SOFAMOR DANEK, INC.
5484315
In Commercial Distribution

  • 00613994761521 ()


  • Manual orthopaedic bender, reusable
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