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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GUIDE 9092130 BURR HOUSING 10MM 8DEG
MEDTRONIC SOFAMOR DANEK, INC.
9092130
In Commercial Distribution

  • 00681490862738 ()


  • General internal orthopaedic fixation system implantation kit
GUIDE 9093000 BURR SPACER
MEDTRONIC SOFAMOR DANEK, INC.
9093000
In Commercial Distribution

  • 00681490862707 ()


  • General internal orthopaedic fixation system implantation kit
DRILL BIT X0101018 SHORT 13MM
MEDTRONIC SOFAMOR DANEK, INC.
X0101018
In Commercial Distribution

  • 00681490860482 ()


  • Bone tap, reusable
INSTRUMENT 8951607 REAMER PLUG 16MM
MEDTRONIC SOFAMOR DANEK, INC.
8951607
In Commercial Distribution

  • 00681490847100 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8951605 16MM ADJUSTABL REAMER
MEDTRONIC SOFAMOR DANEK, INC.
8951605
In Commercial Distribution

  • 00681490847087 ()


  • Orthopaedic broach
CASE 8959162 TAPERED 16MM INS INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
8959162
In Commercial Distribution

  • 00681490847049 ()


  • Instrument tray, reusable
INSTRUMENT 8951815 18 14MM SGL BRL OS DS
MEDTRONIC SOFAMOR DANEK, INC.
8951815
In Commercial Distribution

  • 00681490846974 ()


  • Orthopaedic implantation sleeve, reusable
INSTRUMENT 8951813 18MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951813
In Commercial Distribution

  • 00681490846936 ()


  • Orthopaedic broach
INSTRUMENT 8951615 16 12MM SGL BAR OS DS
MEDTRONIC SOFAMOR DANEK, INC.
8951615
In Commercial Distribution

  • 00681490846929 ()


  • Orthopaedic implantation sleeve, reusable
INSTRUMENT 8951613 16MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951613
In Commercial Distribution

  • 00681490846905 ()


  • Orthopaedic broach
INSTRUMENT 8951413 14MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951413
In Commercial Distribution

  • 00681490846875 ()


  • Orthopaedic broach
INSTRUMENT 8950013 SGL BAR REAM PLG INSR
MEDTRONIC SOFAMOR DANEK, INC.
8950013
In Commercial Distribution

  • 00681490846868 ()


  • Orthopaedic broach
INSTRUMENT 8950005 SGL BARRL OS DRVR CAP
MEDTRONIC SOFAMOR DANEK, INC.
8950005
In Commercial Distribution

  • 00681490846851 ()


  • Orthopaedic implant driver
CASE 8959012 TAPERED SB INST INNTER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
8959012
In Commercial Distribution

  • 00681490846837 ()


  • Instrument tray, reusable
CASE 8959011 TAPERED SB INST BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
8959011
In Commercial Distribution

  • 00681490846820 ()


  • Instrument tray, reusable
INSTRUMENT 8951407 REAMER PLUG 14MM
MEDTRONIC SOFAMOR DANEK, INC.
8951407
In Commercial Distribution

  • 00681490846479 ()


  • Orthopaedic broach
INSTRUMENT 8951405 14MM ADJ REAMER
MEDTRONIC SOFAMOR DANEK, INC.
8951405
In Commercial Distribution

  • 00681490846462 ()


  • Orthopaedic broach
CASE 8959142 TAPERED 14MM INS INTER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
8959142
In Commercial Distribution

  • 00681490846417 ()


  • Instrument tray, reusable
SMOOTH HEMOSTATIC FORCEPS
MEDTRONIC SOFAMOR DANEK, INC.
X0500032
In Commercial Distribution

  • 00681490845854 ()


  • General internal orthopaedic fixation system implantation kit
SHORT MONO DRILL GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1200009
In Commercial Distribution

  • 00681490844680 ()


  • Fluted surgical drill bit, reusable
NARROW ROCKER
MEDTRONIC SOFAMOR DANEK, INC.
X815-500
In Commercial Distribution

  • 00681490843768 ()


  • Surgical implant/trial-implant/sizer holder, reusable
THORACIC PROBE
MEDTRONIC SOFAMOR DANEK, INC.
X0101005
In Commercial Distribution

  • 00681490843751 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
TISSUE RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0101006
In Commercial Distribution

  • 00681490843744 ()


  • Surgical retractor/retraction system blade, reusable
QUICK CONNECT PROBE W/ MARKER
MEDTRONIC SOFAMOR DANEK, INC.
X0101013
In Commercial Distribution

  • 00681490842471 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
FLEXIBLE BAYONET PLATE HOLDER
MEDTRONIC SOFAMOR DANEK, INC.
X0300077
In Commercial Distribution

  • 00681490837934 ()


  • Orthopaedic instrument surgical connector
WIDE-MOUTH COUNTER TORQUE
MEDTRONIC SOFAMOR DANEK, INC.
X0101001
In Commercial Distribution

  • 00681490837927 ()


  • Surgical torque wrench, reusable
METRX DILATOR 24MM
MEDTRONIC SOFAMOR DANEK, INC.
X1100013
In Commercial Distribution

  • 00681490837910 ()


  • Laparoscopic access cannula dilator
MED TUBULAR RETRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X1100011
In Commercial Distribution

  • 00681490837903 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR X1100010 MED TUBULAR
MEDTRONIC SOFAMOR DANEK, INC.
X1100010
In Commercial Distribution

  • 00681490837897 ()


  • Surgical retractor/retraction system blade, reusable
DILATOR X1100009 METRX 26MM
MEDTRONIC SOFAMOR DANEK, INC.
X1100009
In Commercial Distribution

  • 00681490837880 ()


  • Laparoscopic access cannula dilator
7.5MM TAP W/BALL DETENT
MEDTRONIC SOFAMOR DANEK, INC.
X1200015
In Commercial Distribution

  • 00681490635783 ()


  • Bone tap, reusable
5.5MM TAP W/BALL DETENT
MEDTRONIC SOFAMOR DANEK, INC.
X1200013
In Commercial Distribution

  • 00681490635769 ()


  • Bone tap, reusable
18MM SEMI-DISP ENDOSCOPE ATCH
MEDTRONIC SOFAMOR DANEK, INC.
X1200004
In Commercial Distribution

  • 00681490635714 ()


  • Spinal endoscopic-access system
DRILL W/EXTENDED SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X1200011
In Commercial Distribution

  • 00681490615259 ()


  • Surgical drill guide, reusable
20 X 80MM DISCECTOMU BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1100018
In Commercial Distribution

  • 00681490614528 ()


  • Bone trephine, reusable
20 X 80MM LONGITUDINAL BLADE
MEDTRONIC SOFAMOR DANEK, INC.
X1100017
In Commercial Distribution

  • 00681490614511 ()


  • Bone trephine, reusable
M8 LONG ARM BREAKER
MEDTRONIC SOFAMOR DANEK, INC.
X8680047
In Commercial Distribution

  • 00681490614368 ()


  • Orthopaedic rod reducer
INSTRUMENT X8680046 CNTR TRQ
MEDTRONIC SOFAMOR DANEK, INC.
X8680046
In Commercial Distribution

  • 00681490614351 ()


  • Orthopaedic counter-torque/rod-pushing instrument
SCREWDRIVER SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X8760482
In Commercial Distribution

  • 00681490614313 ()


  • Orthopaedic implantation sleeve, reusable
7.5MM EGG HANDLE TAP
MEDTRONIC SOFAMOR DANEK, INC.
X1200003
In Commercial Distribution

  • 00681490612012 ()


  • Bone tap, reusable
6.5MM EGG HANDLE TAP
MEDTRONIC SOFAMOR DANEK, INC.
X1200002
In Commercial Distribution

  • 00681490612005 ()


  • Bone tap, reusable
5.5MM EGG HANDLE TAP
MEDTRONIC SOFAMOR DANEK, INC.
X1200001
In Commercial Distribution

  • 00681490611992 ()


  • Bone tap, reusable
LARGE RANDLE SCRWDRVR
MEDTRONIC SOFAMOR DANEK, INC.
X1200007
In Commercial Distribution

  • 00681490611978 ()


  • Orthopaedic implant driver
HOLDER X0300076 BAYONET PLT HOLDR 1 INCH
MEDTRONIC SOFAMOR DANEK, INC.
X0300076
In Commercial Distribution

  • 00681490611923 ()


  • Bone distraction forceps
BAYON CUR REV ANG. CUP 3.6MM
MEDTRONIC SOFAMOR DANEK, INC.
X9560625
In Commercial Distribution

  • 00681490611909 ()


  • Bone curette, reusable
CUR X9560621 BAYON REV STR CUP 3.6 MM
MEDTRONIC SOFAMOR DANEK, INC.
X9560621
In Commercial Distribution

  • 00681490611893 ()


  • Bone curette, reusable
INSTRUMENT 8572021 LOW PRFLE CRSSLNK PLT
MEDTRONIC SOFAMOR DANEK, INC.
8572021
In Commercial Distribution

  • 00681490611329 ()


  • Surgical implant template, reusable
2MM DRILL - TIR TIP 15MM
MEDTRONIC SOFAMOR DANEK, INC.
X8796014
In Commercial Distribution

  • 00681490571777 ()


  • Fluted surgical drill bit, reusable
4.0 X 13MM TAP W/ SOLID HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1100016
In Commercial Distribution

  • 00681490570169 ()


  • Bone tap, reusable
ADJUSTABLE DUAL DYN SLOT GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1000014
In Commercial Distribution

  • 00681490533638 ()


  • General internal orthopaedic fixation system implantation kit
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