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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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SHAFT 7480741T ADAPTER DRIVER QC SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
7480741T
In Commercial Distribution

  • 00643169679405 ()


  • Orthopaedic implant driver
ADAPTER X0815099 OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X0815099
In Commercial Distribution

  • 00643169674592 ()


  • Orthopaedic implant driver
DRIVER X0815096 OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X0815096
In Commercial Distribution

  • 00643169674561 ()


  • Orthopaedic implant driver
DRIVER X0715045 NUT 20MM 3-LUG
MEDTRONIC SOFAMOR DANEK, INC.
X0715045
In Commercial Distribution

  • 00643169662667 ()


  • Orthopaedic implant driver
DRIVER EX0116014 T25 RETAINING TWIST
MEDTRONIC SOFAMOR DANEK, INC.
EX0116014
In Commercial Distribution

  • 00643169723351 ()


  • Surgical screwdriver, reusable
SLEEVE EX1015066 SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1015066
In Commercial Distribution

  • 00643169722200 ()


  • Orthopaedic implantation sleeve, reusable
STARTER 5580135 SETSCREW T27
MEDTRONIC SOFAMOR DANEK, INC.
5580135
In Commercial Distribution

  • 00643169714731 ()


  • Surgical screwdriver, reusable
DRIVER EX0416035 5.5/6.0 FAS
MEDTRONIC SOFAMOR DANEK, INC.
EX0416035
In Commercial Distribution

  • 00643169764194 ()


  • Surgical screwdriver, reusable
DRIVER 6550006 5.5/6.0 SV SET SCREW DRVR
MEDTRONIC SOFAMOR DANEK, INC.
6550006
In Commercial Distribution

  • 00643169754539 ()


  • Surgical screwdriver, reusable
DRIVER NAV6550005 5.5/6.0 SV NAV MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV6550005
In Commercial Distribution

  • 00643169754522 ()


  • Surgical screwdriver, reusable
DRIVER 6550004 BALL-ENDED DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550004
In Commercial Distribution

  • 00643169754515 ()


  • Surgical screwdriver, reusable
DRIVER 6550003 5.5/6.0 SV NON-RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
6550003
In Commercial Distribution

  • 00643169754508 ()


  • Surgical screwdriver, reusable
DRIVER 6550002 5.5/6.0 SV MAS DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550002
In Commercial Distribution

  • 00643169754492 ()


  • Surgical screwdriver, reusable
DRIVER EX0316044 T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0316044
In Commercial Distribution

  • 00643169747678 ()


  • Orthopaedic implant driver
DRIVER EX0216058 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0216058
In Commercial Distribution

  • 00643169746831 ()


  • Surgical instrument handle, non-torque-limiting
DRIVER EX0216057 THREADED ROD
MEDTRONIC SOFAMOR DANEK, INC.
EX0216057
In Commercial Distribution

  • 00643169746824 ()


  • Surgical instrument handle, non-torque-limiting
DRIVER X0116073 PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
X0116073
In Commercial Distribution

  • 00643169731530 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX0116074 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0116074
In Commercial Distribution

  • 00643169731462 ()


  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER NAV3606195 NAVIGATD THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV3606195
In Commercial Distribution

  • 00643169725461 ()


  • Surgical screwdriver, reusable
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000953 ()
Reconstruction Planner

  • CAD/CAM software
Materialise Mimics Enlight CMF Orthognathic and Trauma Planner
Materialise NV
Orthognathic and Trauma Planner
In Commercial Distribution

  • 05404028000946 ()
Orthognathic and Trauma Planner

  • CAD/CAM software
Mimics Enlight CMF Reconstruction Planner
Materialise NV
Reconstruction Planner
In Commercial Distribution

  • 05404028000816 ()
Reconstruction Planner

  • CAD/CAM software
Flexible Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-023
In Commercial Distribution

  • 05397283000212 ()


  • Surgical screwdriver, reusable
Short Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-022
In Commercial Distribution

  • 05397283000205 ()


  • Surgical screwdriver, reusable
Long Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-021
In Commercial Distribution

  • 05397283000199 ()


  • Surgical screwdriver, reusable
T20 Torx screwdriver (4.5Nm Torque Limit)
X-BOLT ORTHOPEDICS INC.
XNI-020
In Commercial Distribution

  • 05397283000182 ()


  • Surgical screwdriver, reusable
Mimics Enlight CMF Orthognathic Planner
Materialise NV
Orthognathic Planner
In Commercial Distribution

  • 05404028000809 ()
Orthognathic Planner

  • CAD/CAM software
DRIVER 7480745T 4.75 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
7480745T
In Commercial Distribution

  • 00643169679412 ()


  • Orthopaedic implant driver
DRIVER NAV2081K VERT THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV2081K
In Commercial Distribution

  • 00643169672857 ()


  • Surgical screwdriver, reusable
DRIVER EX0615015 BONESCREW T-25
MEDTRONIC SOFAMOR DANEK, INC.
EX0615015
In Commercial Distribution

  • 00643169652224 ()


  • Surgical screwdriver, reusable
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