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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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Medtronic Resuable Instruments - 00643169859784

DRIVER EX0816038 T8-10 WITH BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0816038
In Commercial Distribution

  • 00643169859784 ()


  • Surgical screwdriver, reusable

N/A - 00643169731530

DRIVER X0116073 PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
X0116073
In Commercial Distribution

  • 00643169731530 ()


  • General internal orthopaedic fixation system implantation kit

Medtronic Resuable Instruments - 00643169731462

DRIVER EX0116074 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0116074
In Commercial Distribution

  • 00643169731462 ()


  • General internal orthopaedic fixation system implantation kit

Medtronic Resuable Instruments - 00643169713949

SCREWDRIVER X1215024 LNG MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1215024
In Commercial Distribution

  • 00643169713949 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169713666

DRIVER EX1115089 TAPERED T27 243MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1115089
In Commercial Distribution

  • 00643169713666 ()


  • Orthopaedic implant driver

Apex - 05391529583057

Flexible IM reamer Shaft 470mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1095
In Commercial Distribution

  • 05391529583057 ()

  • 470.0 mm
INS-1095

  • Medullary canal orthopaedic reamer shaft

Apex - 05391529582883

Long Screw Hex Driver (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1078
In Commercial Distribution

  • 05391529582883 ()
INS-1078

  • Surgical screwdriver, reusable

Apex - 05391529582876

Short Screw Hex Driver (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1077
In Commercial Distribution

  • 05391529582876 ()
INS-1077

  • Surgical screwdriver, reusable

Apex - 05391529582869

Short Screw Driver With Retention Hex (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1076
In Commercial Distribution

  • 05391529582869 ()
INS-1076

  • Surgical screwdriver, reusable

Apex - 05391529582852

Hex Driver (5mm/8mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1075
In Commercial Distribution

  • 05391529582852 ()
INS-1075

  • Surgical screwdriver, reusable

Apex - 05391529582760

Mallet
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1065
In Commercial Distribution

  • 05391529582760 ()
INS-1065

  • Surgical mallet

Apex - 05391529582739

Long Screw Driver With Retention Hex (3.5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1060
In Commercial Distribution

  • 05391529582739 ()
INS-1060

  • Surgical screwdriver, reusable

Apex - 05391529582722

Driver With Retention Hex (5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1059
In Commercial Distribution

  • 05391529582722 ()
INS-1059

  • Surgical screwdriver, reusable

Apex - 05391529581855

Long Removal and Insertion Hex (5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1136
In Commercial Distribution

  • 05391529581855 ()
INS-1136

  • Surgical screwdriver, reusable

Apex - 05391529581640

Flexible IM Reamer Shaft Extension 150mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1135
In Commercial Distribution

  • 05391529581640 ()

  • 150 mm
INS-1135

  • Medullary canal orthopaedic reamer shaft

S-Core™ - 00850017962422

T10 Torque Driver
SUBCHONDRAL SOLUTIONS, INC.
10-4010
In Commercial Distribution

  • 00850017962422 ()
10-4010

  • Orthopaedic bone screw, non-bioabsorbable, sterile

Amplion Care Assurance - 00850016398024

Alert Display Driver (ADD) - Configuration 2 (curved)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-2
Not in Commercial Distribution

  • 00850016398024 ()
D-ADD-X-2

  • Nurse call system

Amplion Care Assurance - 00850016398017

Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system

Medtronic Reusable Instruments - 00643169585676

DRIVER 5482300 5/16 REVISION DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5482300
In Commercial Distribution

  • 00643169585676 ()


  • Orthopaedic implant driver

TiMesh® - 00643169582934

TRAY 8004200 BATTERY POWERED DRIVER
MEDTRONIC PS MEDICAL, INC.
8004200
In Commercial Distribution

  • 00643169582934 ()


  • Instrument tray, reusable
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