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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 Reusable Instruments - 00643169173293

DRIVER EX0412058 SHORT T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0412058
In Commercial Distribution

  • 00643169173293 ()


  • Surgical drill guide, reusable

N.A. - J011051025000

Hard metal tip, straight (for Eby band seater REF 051-023-00)
DENTAURUM GmbH & Co.KG
051-025-00
Not in Commercial Distribution

  • J011051025000 ()


  • Orthodontic metal band pusher

N.A. - J011051023000

Eby band seater, curved, Stainless steel
DENTAURUM GmbH & Co.KG
051-023-00
Not in Commercial Distribution

  • J011051023000 ()


  • Orthodontic metal band pusher

N.A. - J011051022000

Exchange Tip,Straight
DENTAURUM GmbH & Co.KG
051-022-00
Not in Commercial Distribution

  • J011051022000 ()


  • Orthodontic metal band pusher

PYRENEES® Cervical Plate System - 10888857261761

Drill, Size Dia. 2.3x16 mm
K2M, INC.
6808-90028
In Commercial Distribution

  • 10888857261761 ()
6808-90028

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261754

Drill, Size Dia. 2.3x14 mm
K2M, INC.
6808-90027
In Commercial Distribution

  • 10888857261754 ()
6808-90027

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261747

Drill, Size Dia. 2.3x12 mm
K2M, INC.
6808-90026
In Commercial Distribution

  • 10888857261747 ()
6808-90026

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261730

Drill, Size Dia. 2.3x10 mm
K2M, INC.
6808-90025
In Commercial Distribution

  • 10888857261730 ()
6808-90025

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261686

Single Barrel Drill, Size Dia. 2.3x16 mm
K2M, INC.
6808-90022
In Commercial Distribution

  • 10888857261686 ()
6808-90022

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261679

Single Barrel Drill, Size Dia. 2.3x14 mm
K2M, INC.
6808-90021
In Commercial Distribution

  • 10888857261679 ()
6808-90021

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261662

Single Barrel Drill, Size Dia. 2.3x12 mm
K2M, INC.
6808-90020
In Commercial Distribution

  • 10888857261662 ()
6808-90020

  • Cannulated surgical drill bit, single-use

PYRENEES® Cervical Plate System - 10888857261655

Single Barrel Drill, Size Dia. 2.3x10 mm
K2M, INC.
6808-90015
In Commercial Distribution

  • 10888857261655 ()
6808-90015

  • Cannulated surgical drill bit, single-use

RAVINE® Lateral Access System - 10888857247758

Fixation Pin Driver, Size 15 Long
K2M, INC.
SP-1361
In Commercial Distribution

  • 10888857247758 ()

  • Size 15 Hexalobe
SP-1361

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAYMAN Plate System - 10888857247734

Capture Driver, Sleeve
K2M, INC.
SP-1344-02
In Commercial Distribution

  • 10888857247734 ()
SP-1344-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CHESAPEAKE Stabilization System - 10888857247659

Universal Driver Size Tapered, Size 20
K2M, INC.
SP-1282
In Commercial Distribution

  • 10888857247659 ()
SP-1282

  • Surgical screwdriver, reusable

PYRENEES Cervical Plate System - 10888857247321

Inner Shaft Removal Driver
K2M, INC.
6712-90001
In Commercial Distribution

  • 10888857247321 ()
6712-90001

  • Orthopaedic prosthesis implantation positioning instrument, reusable

PYRENEES Cervical Plate System - 10888857247314

Retaining Driver Size 13
K2M, INC.
6712-90000
In Commercial Distribution

  • 10888857247314 ()
6712-90000

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAYMAN Plate System - 10888857247185

Capture Driver Size 25
K2M, INC.
SP-1344-01
In Commercial Distribution

  • 10888857247185 ()
SP-1344-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

RAVINE Lateral Access System - 10888857243842

Fixation Pin Driver Size 15
K2M, INC.
K2-27-2014-01
In Commercial Distribution

  • 10888857243842 ()
K2-27-2014-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

SANTORINI™ Corpectomy Cage System - 10888857243187

Non-Tapered Driver, Size 15
K2M, INC.
K2-17-2024-01
In Commercial Distribution

  • 10888857243187 ()
K2-17-2024-01

  • Orthopaedic implant driver

CASPIAN Spinal System - 10888857242739

Universal Joint Driver, Hex Size 15
K2M, INC.
K2-11-2279-01
In Commercial Distribution

  • 10888857242739 ()
K2-11-2279-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857242586

Reduction Jack Rotation Tube, w/Driver
K2M, INC.
K2-11-2213-01
In Commercial Distribution

  • 10888857242586 ()
K2-11-2213-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857242234

Tapered Double Ended Driver Size 15
K2M, INC.
K2-11-2047-01
In Commercial Distribution

  • 10888857242234 ()
K2-11-2047-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CASPIAN Spinal System - 10888857242227

Torque Limiting Driver Size 15
K2M, INC.
K2-11-2042-01
In Commercial Distribution

  • 10888857242227 ()
K2-11-2042-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

PYRENEES Cervical Plate System - 10888857241886

Capture Driver
K2M, INC.
K2-02-2189-01
In Commercial Distribution

  • 10888857241886 ()
K2-02-2189-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00643169060715

DRIVER X0811006 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
X0811006
In Commercial Distribution

  • 00643169060715 ()


  • Surgical screwdriver, reusable

n/a - 00643169059917

DRIVER EX0811006 4.75 (TOGGLE FREE)
MEDTRONIC SOFAMOR DANEK, INC.
EX0811006
In Commercial Distribution

  • 00643169059917 ()


  • General internal orthopaedic fixation system implantation kit

EVEREST Spinal System - 10888857160293

Cannulated Driver, Height Adjustment Size 25
K2M, INC.
5101-90107
In Commercial Distribution

  • 10888857160293 ()
5101-90107

  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169022317

DRIVER EX0611151 LOCK SLEEVE L=285
MEDTRONIC SOFAMOR DANEK, INC.
EX0611151
In Commercial Distribution

  • 00643169022317 ()


  • General internal orthopaedic fixation system implantation kit

N/A - 00643169051393

NUT DRIVER EX0711001 EXTENDED
MEDTRONIC SOFAMOR DANEK, INC.
EX0711001
In Commercial Distribution

  • 00643169051393 ()


  • Orthopaedic implant driver
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