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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POSITIONER EX0418108 5.5/6.0MM HEAD
MEDTRONIC SOFAMOR DANEK, INC.
EX0418108
In Commercial Distribution

  • 00763000153328 ()


  • Orthopaedic fixation implant alignment tool
POSITIONER EX0418107 4.75MM HEAD
MEDTRONIC SOFAMOR DANEK, INC.
EX0418107
In Commercial Distribution

  • 00763000153311 ()


  • Orthopaedic fixation implant alignment tool
TAP EX0418021 3.5MM TROCAR TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0418021
In Commercial Distribution

  • 00763000153281 ()


  • Bone tap, reusable
TAP EX0418020 3.0MM TROCAR TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0418020
In Commercial Distribution

  • 00763000153274 ()


  • Bone tap, reusable
DILATOR EX0418112 16.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0418112
In Commercial Distribution

  • 00763000152758 ()


  • Laparoscopic access cannula dilator
DILATOR EX0418111 12.8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0418111
In Commercial Distribution

  • 00763000152741 ()


  • Laparoscopic access cannula dilator
CUTTER X0318020 TBLE TOP ROD REMVLE HNDL
MEDTRONIC SOFAMOR DANEK, INC.
X0318020
In Commercial Distribution

  • 00763000142414 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
RETRACTOR X0418050 12MM X 6CM TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
X0418050
In Commercial Distribution

  • 00763000141486 ()


  • Surgical retractor/retraction system blade, reusable
AWL EX0318087 ROUND SHARP BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0318087
In Commercial Distribution

  • 00763000141455 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PENFIELD EX0418054 STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0418054
In Commercial Distribution

  • 00763000141448 ()


  • Open-surgery dissector
SPREADER EX0418017 LARGER PADDLES
MEDTRONIC SOFAMOR DANEK, INC.
EX0418017
In Commercial Distribution

  • 00763000141431 ()


  • Bone distraction forceps
TAP EX0418057 CANNULATED 5.5 X 30
MEDTRONIC SOFAMOR DANEK, INC.
EX0418057
In Commercial Distribution

  • 00763000141394 ()


  • Bone tap, reusable
TAP EX0418056 SOLID 5.5 X 30
MEDTRONIC SOFAMOR DANEK, INC.
EX0418056
In Commercial Distribution

  • 00763000141387 ()


  • Bone tap, reusable
DRIVER EX0418055 CANNULATED
MEDTRONIC SOFAMOR DANEK, INC.
EX0418055
In Commercial Distribution

  • 00763000141370 ()


  • Surgical screwdriver, reusable
SLEEVE X0318045 NIM PROBE
MEDTRONIC SOFAMOR DANEK, INC.
X0318045
In Commercial Distribution

  • 00763000140496 ()


  • Laparoscopic access cannula, reusable
CURETTE X0818049 SIZE5 90DEG PUSH
MEDTRONIC SOFAMOR DANEK, INC.
X0818049
In Commercial Distribution

  • 00763000210656 ()


  • Bone curette, reusable
CURETTE X0818047 8MM RING
MEDTRONIC SOFAMOR DANEK, INC.
X0818047
In Commercial Distribution

  • 00763000210625 ()


  • Bone curette, reusable
HANDLE EX0418104 FUNNEL
MEDTRONIC SOFAMOR DANEK, INC.
EX0418104
In Commercial Distribution

  • 00763000208608 ()


  • Bone graft funnel
FUNNEL EX0418103 OVAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0418103
In Commercial Distribution

  • 00763000208592 ()


  • Bone graft funnel
TAMP EX0418102 OVAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0418102
In Commercial Distribution

  • 00763000208585 ()


  • Surgical tamp, reusable
REDUCER X0918005 4.75MM REDUCER
MEDTRONIC SOFAMOR DANEK, INC.
X0918005
In Commercial Distribution

  • 00763000206123 ()


  • Orthopaedic rod reducer
HANDLE X0212010 METRX TUBE
MEDTRONIC SOFAMOR DANEK, INC.
X0212010
In Commercial Distribution

  • 00763000205928 ()


  • Surgical retractor/retraction system blade, reusable
CURETTE EX0918003 DNFCNG 90 BYNT CUP 5.5
MEDTRONIC SOFAMOR DANEK, INC.
EX0918003
In Commercial Distribution

  • 00763000205904 ()


  • Bone curette, reusable
DISSECTOR X0918018 ANTERIOR RIB
MEDTRONIC SOFAMOR DANEK, INC.
X0918018
In Commercial Distribution

  • 00763000205751 ()


  • Open-surgery dissector
CHISEL X0918017 ANTERIOR 10MM
MEDTRONIC SOFAMOR DANEK, INC.
X0918017
In Commercial Distribution

  • 00763000205744 ()


  • Orthopaedic osteotome
COUTER TORQUE EX0918013 DL HDL CSD 5.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0918013
In Commercial Distribution

  • 00763000205157 ()


  • Orthopaedic counter-torque/rod-pushing instrument
POSITIONER EX0918001 4.75 HEAD
MEDTRONIC SOFAMOR DANEK, INC.
EX0918001
In Commercial Distribution

  • 00763000204068 ()


  • Orthopaedic fixation implant alignment tool
DRILL BIT EX0918010 SHORT 11MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0918010
In Commercial Distribution

  • 00763000201944 ()


  • Drilling power tool attachment, basic
IMPACTOR X0718055 STAPLE WITH AWL
MEDTRONIC SOFAMOR DANEK, INC.
X0718055
In Commercial Distribution

  • 00763000200626 ()


  • Orthopaedic implant impactor, reusable
GUIDE EX0618049 DTS ASSY 12DEG SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0618049
In Commercial Distribution

  • 00763000200305 ()


  • Surgical drill guide, reusable
GUIDE EX0618048 DTS ASSY 0DEG SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX0618048
In Commercial Distribution

  • 00763000200299 ()


  • Surgical drill guide, reusable
PROBE EX0818002 BALL HANDLE CURVED
MEDTRONIC SOFAMOR DANEK, INC.
EX0818002
In Commercial Distribution

  • 00763000195120 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
DISTRACTOR X0611076 6MM
MEDTRONIC SOFAMOR DANEK, INC.
X0611076
In Commercial Distribution

  • 00763000194604 ()


  • Orthopaedic surgical distractor, internal
CURETTE EX0818042 SERTED CUP ANGD SIZ 5
MEDTRONIC SOFAMOR DANEK, INC.
EX0818042
In Commercial Distribution

  • 00763000194598 ()


  • Bone curette, reusable
CANNULA X1119023 REUSABLE
MEDTRONIC SOFAMOR DANEK, INC.
X1119023
In Commercial Distribution

  • 00763000388942 ()


  • Bone access cannula
STYLET X1119022 REUSABLE TROCAR
MEDTRONIC SOFAMOR DANEK, INC.
X1119022
In Commercial Distribution

  • 00763000388935 ()


  • Bone access cannula
STYLET X1119021 REUSABLE BEVELED
MEDTRONIC SOFAMOR DANEK, INC.
X1119021
In Commercial Distribution

  • 00763000388928 ()


  • Bone access cannula
11mm Double Sided Rasp
MEDTRONIC SOFAMOR DANEK, INC.
EX0420050
In Commercial Distribution

  • 00763000388911 ()


  • Bone file/rasp, manual, reusable
STATION EX0420049 GRAFT PACKING
MEDTRONIC SOFAMOR DANEK, INC.
EX0420049
In Commercial Distribution

  • 00763000387068 ()


  • Bone graft packing block
TAB BREAKER EX1019003 5.5/6 RMAS BI-DRTN
MEDTRONIC SOFAMOR DANEK, INC.
EX1019003
In Commercial Distribution

  • 00763000386634 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SCREWDRIVER X0320008 5.5 MAS W/OUT T-BAR
MEDTRONIC SOFAMOR DANEK, INC.
X0320008
In Commercial Distribution

  • 00763000386573 ()


  • Surgical screwdriver, reusable
REMOVER X1219005 CL INSERTER SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1219005
In Commercial Distribution

  • 00763000383312 ()


  • Orthopaedic implantation hammering attachment
HANDLE EX0320004 BALL
MEDTRONIC SOFAMOR DANEK, INC.
EX0320004
In Commercial Distribution

  • 00763000380809 ()


  • Surgical instrument handle, non-torque-limiting
RONGEUR X1119018 CURVED
MEDTRONIC SOFAMOR DANEK, INC.
X1119018
In Commercial Distribution

  • 00763000378844 ()


  • Orthopaedic joint/limb rongeur
COBB X1119017 CURVED 18MM WIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1119017
In Commercial Distribution

  • 00763000378837 ()


  • Bone lever/elevator, reusable
COBB X1119016 CURVED 10MM WIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1119016
In Commercial Distribution

  • 00763000378820 ()


  • Bone lever/elevator, reusable
TRIAL X1119014 CURVED H12XW22-12DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119014
In Commercial Distribution

  • 00763000378813 ()


  • Surgical implant template, reusable
TRIAL X1119013 CURVED H10XW22-12DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119013
In Commercial Distribution

  • 00763000378806 ()


  • Surgical implant template, reusable
TRIAL X1119011 CURVED H12XW18-6DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119011
In Commercial Distribution

  • 00763000378790 ()


  • Surgical implant template, reusable
TRIAL X1119010 CURVED H10XW18-6DEG
MEDTRONIC SOFAMOR DANEK, INC.
X1119010
In Commercial Distribution

  • 00763000378783 ()


  • Surgical implant template, reusable
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