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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 - 00643169191440

DRIVER X0512188 5.5 MAS T-25 OSTEOGRIP
MEDTRONIC SOFAMOR DANEK, INC.
X0512188
In Commercial Distribution

  • 00643169191440 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169190153

MIDLINE TEMPLATE X0512213 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
X0512213
In Commercial Distribution

  • 00643169190153 ()


  • Surgical screwdriver, reusable

CHESAPEAKE Stabilization System - 10888857182752

Universal Tapered Driver Size 20
K2M, INC.
2008-90174
In Commercial Distribution

  • 10888857182752 ()
2008-90174

  • Orthopaedic prosthesis implantation positioning instrument, reusable

EVEREST Spinal System - 10888857160293

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

  • 10888857160293 ()
5101-90107

  • Orthopaedic implant driver

EVEREST Spinal System - 10888857160286

Torque Limiting Shaft (Long) Size 30
K2M, INC.
5101-90106
In Commercial Distribution

  • 10888857160286 ()
5101-90106

  • Surgical screwdriver, reusable

NILE Alternative Fixation System - 10888857152939

Socket Driver
K2M, INC.
5401-90005
In Commercial Distribution

  • 10888857152939 ()
5401-90005

  • Orthopaedic prosthesis implantation positioning instrument, reusable

EVEREST Spinal System - 10888857213074

Set Screw Driver Base Camp
K2M, INC.
2901-90164
In Commercial Distribution

  • 10888857213074 ()
2901-90164

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAPRI Corpectomy Cage System - 10888857211582

Driver Size 20
K2M, INC.
2112-90019
In Commercial Distribution

  • 10888857211582 ()
2112-90019

  • Orthopaedic prosthesis implantation positioning instrument, reusable

EVEREST Spinal System - 10888857210141

Provisional Split Driver Size 30
K2M, INC.
5101-90129
In Commercial Distribution

  • 10888857210141 ()
5101-90129

  • Orthopaedic implant driver

RAVINE® Lateral Access System - 10888857210080

Hexalobe Screwdriver Size 7 mm
K2M, INC.
2701-90176
In Commercial Distribution

  • 10888857210080 ()
2701-90176

  • Surgical screwdriver, reusable

SAHARA Stabilization System - 10888857209879

Non-Tapered Hexalobe Driver Size 13
K2M, INC.
5808-90023
In Commercial Distribution

  • 10888857209879 ()
5808-90023

  • Orthopaedic implant driver

SAHARA Stabilization System - 10888857209862

Non-Tapered Hexalobe Driver Size 8
K2M, INC.
5808-90001
In Commercial Distribution

  • 10888857209862 ()
5808-90001

  • Orthopaedic implant driver

ALEUTIAN Interbody Systems - 10888857189324

Angled Lateral Inserter Driver
K2M, INC.
K2-32-2056-03
In Commercial Distribution

  • 10888857189324 ()
K2-32-2056-03

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MESA Small Stature Spinal System - 10888857186477

Tapered Driver Size 20
K2M, INC.
K2-30-2020-01
In Commercial Distribution

  • 10888857186477 ()
K2-30-2020-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MESA Small Stature Spinal System - 10888857186392

Reduction Jack Rotation Tube, w/Driver
K2M, INC.
K2-30-2012-01
In Commercial Distribution

  • 10888857186392 ()
K2-30-2012-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Power Dental U.S.A., Inc. - D943N4226T00

MALLET MEAD MINI FOR IMPLANT, TIPS
Power Dental U.S.A. Inc.
N4226T
In Commercial Distribution

  • D943N4226T00 ()
N4226T

  • Surgical mallet

Power Dental U.S.A., Inc. - D943N4223TROUND00

MALLET MEAD1 ROUND TIPS
Power Dental U.S.A. Inc.
N4223T-Round
Not in Commercial Distribution

  • D943N4223TROUND00 ()
N4223T-Round

  • Surgical mallet

Power Dental U.S.A., Inc. - D943N4223MTROUND00

MEAD MINI/ ROUND TIPS
Power Dental U.S.A. Inc.
N4223MT-Round
In Commercial Distribution

  • D943N4223MTROUND00 ()
N4223MT-Round

  • Surgical mallet

Power Dental U.S.A., Inc. - D943N4223

MALLET MEAD1, REMOVE PLASTICS ENDS OF MALLET WHEN PUTTING INTO AUTOCLAVE. CLEAN WITH COLD STERILIZATION AND AUTOCLAVE (<120*C / 248 °F )
Power Dental U.S.A. Inc.
N4223
Not in Commercial Distribution

  • D943N4223 ()
N4223

  • Surgical mallet

Power Dental U.S.A., Inc. - D943N1984N00

TORQUE DRIVER
Power Dental U.S.A. Inc.
N1984N
In Commercial Distribution

  • D943N1984N00 ()
N1984N

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Power Dental USA - D94378307

SPECIAL CASSETTE FOR X EASY BONE EXPANDER / SINUS LIFT / ROOT EXTRACTION WITH UNIVERSAL LATCHET DRIVER SET OF 7
Power Dental U.S.A. Inc.
7830-7
In Commercial Distribution

  • D94378307 ()
7830-7

  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable
  • Dressing/utility forceps, scissors-like, reusable

Power Dental USA - D943783060

X UNVERSAL LATCHET DRIVER (FOR LOW SPEED HANDPIECE BUR)
Power Dental U.S.A. Inc.
7830-6
In Commercial Distribution

  • D943783060 ()
7830-6

  • Dressing/utility forceps, scissors-like, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Power Dental USA - D94378303

IMPLANT HEX DRIVER 2.5mm
Power Dental U.S.A. Inc.
7830-3
In Commercial Distribution

  • D94378303 ()
7830-3

  • Dressing/utility forceps, scissors-like, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Power Dental USA - D9437830

X EASY BONE EXPANDER / SINUS LIFT / ROOT EXTRACTION WITH UNIVERSAL LATCHET DRIVER, SET OF 7
Power Dental U.S.A. Inc.
7830
In Commercial Distribution

  • D9437830 ()
7830

  • Dressing/utility forceps, scissors-like, reusable
  • Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Power Dental USA - D943781850

HANDPIECE REMOVER DRIVER
Power Dental U.S.A. Inc.
7818-5
In Commercial Distribution

  • D943781850 ()
7818-5

  • Dressing/utility forceps, scissors-like, reusable
  • Intraoperative orthopaedic bone pin/screw, single-use

MOJAVE Expandable Interbody System - 10888857394025

Expansion Driver, Size Long
K2M, INC.
7012-90094
In Commercial Distribution

  • 10888857394025 ()
7012-90094

  • Orthopaedic prosthesis implantation positioning instrument, reusable

MOJAVE Expandable Interbody System - 10888857391697

Driver, Size 8
K2M, INC.
7012-90095
In Commercial Distribution

  • 10888857391697 ()
7012-90095

  • Orthopaedic prosthesis implantation positioning instrument, reusable

EVEREST Spinal System - 10888857389175

Provisional Screwdriver (Long) Size 30
K2M, INC.
2901-90215
In Commercial Distribution

  • 10888857389175 ()
2901-90215

  • Orthopaedic implant driver

EVEREST Spinal System - 10888857389168

Provisional Screwdriver (Short) Size 30
K2M, INC.
2901-90214
In Commercial Distribution

  • 10888857389168 ()
2901-90214

  • Orthopaedic implant driver

MESA Spinal System - 10888857386570

Driver Cricket 2
K2M, INC.
6201-90095
In Commercial Distribution

  • 10888857386570 ()
6201-90095

  • Orthopaedic implant driver

OZARK Cervical Plate System - 10888857384200

FAST Tapered Driver Size 10
K2M, INC.
8801-90033
In Commercial Distribution

  • 10888857384200 ()
8801-90033

  • Orthopaedic implant driver

CASCADIA Interbody System - 10888857383715

Plate Assembly Driver Tapered
K2M, INC.
7902-90034
In Commercial Distribution

  • 10888857383715 ()
7902-90034

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CHESAPEAKE Stabilization System - 10888857383494

Universal Driver Size 20
K2M, INC.
SP-2460
In Commercial Distribution

  • 10888857383494 ()

  • Size 20 Hexalobe
SP-2460

  • Orthopaedic prosthesis implantation positioning instrument, reusable

YUKON OCT Spinal System - 10888857383104

90° Driver Size 20
K2M, INC.
7601-90132
In Commercial Distribution

  • 10888857383104 ()
7601-90132

  • Orthopaedic prosthesis implantation positioning instrument, reusable

YUKON OCT Spinal System - 10888857383098

90° Driver Size 20 Tapered
K2M, INC.
7601-90130
In Commercial Distribution

  • 10888857383098 ()
7601-90130

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAPRI™ Corpectomy Cage System - 10888857361928

Tapered Driver, Size Size 10
K2M, INC.
7501-90024
In Commercial Distribution

  • 10888857361928 ()
7501-90024

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAPRI™ Corpectomy Cage System - 10888857361911

Driver Height/Angle
K2M, INC.
7501-90025
In Commercial Distribution

  • 10888857361911 ()
7501-90025

  • Orthopaedic prosthesis implantation positioning instrument, reusable

CAPRI™ Corpectomy Cage System - 10888857361904

Non-Tapered Driver, Size Size 10
K2M, INC.
7501-90026
In Commercial Distribution

  • 10888857361904 ()
7501-90026

  • Orthopaedic prosthesis implantation positioning instrument, reusable

tomas® - J011302251000

tomas® anchorage system: tomas®-tool set S / contains the instruments to insert a tomas®-pin/ For further information please visit our online-shop on www.dentaurum.de
DENTAURUM GmbH & Co.KG
302-251-00
In Commercial Distribution

  • J011302251000 ()


  • Surgical screwdriver, reusable

tomas® - J011302156000

tomas®-tool tray for storage of tomas®-components
DENTAURUM GmbH & Co.KG
302-156-00
In Commercial Distribution

  • J011302156000 ()


  • Surgical screwdriver, reusable

tomas® - J011302151000

tomas® anchorage system: tomas®-tool set XL/cont.all instr.for man.& mech.insertion of tomas®-pins/ For further information please visit our online-shop on www.dentaurum.de
DENTAURUM GmbH & Co.KG
302-151-00
In Commercial Distribution

  • J011302151000 ()


  • Surgical screwdriver, reusable

tomas® - J011302080000

tomas® anchorage system: tomas® guide driver / For further information please visit our online-shop on our website www.dentaurum.de
DENTAURUM GmbH & Co.KG
302-080-00
In Commercial Distribution

  • J011302080000 ()


  • Surgical screwdriver, reusable

tomas® - J011302004800

tomas® anchorage system: tomas®-handpiece (Manually turned unit)
DENTAURUM GmbH & Co.KG
302-004-80
Not in Commercial Distribution

  • J011302004800 ()


  • Surgical screwdriver, reusable

tomas® - J011302004700

tomas® anchorage system: tomas®-applicator (manual screwing aid), long version
DENTAURUM GmbH & Co.KG
302-004-70
In Commercial Distribution

  • J011302004700 ()


  • Surgical screwdriver, reusable

tomas® - J011302004600

tomas® anchorage system: tomas®-driver (mechanical screwing aid), long version
DENTAURUM GmbH & Co.KG
302-004-60
In Commercial Distribution

  • J011302004600 ()


  • Surgical screwdriver, reusable

tomas® - J011302004500

tomas® anchorage system: tomas®-driver (mechanical screwing aid)
DENTAURUM GmbH & Co.KG
302-004-50
In Commercial Distribution

  • J011302004500 ()


  • Surgical screwdriver, reusable

tomas® - J011302004410

tomas® anchorage system: tomas® torque ratchet
DENTAURUM GmbH & Co.KG
302-004-41
In Commercial Distribution

  • J011302004410 ()


  • Surgical screwdriver, reusable

tomas® - J011302004400

tomas® anchorage system: tomas®-torque ratchet / For further information please visit our online-shop on our website www.dentaurum.de
DENTAURUM GmbH & Co.KG
302-004-40
Not in Commercial Distribution

  • J011302004400 ()


  • Surgical screwdriver, reusable

tomas® - J011302004300

tomas® anchorage system: tomas®-wheel, ø 10 mm (Nut)
DENTAURUM GmbH & Co.KG
302-004-30
In Commercial Distribution

  • J011302004300 ()


  • Surgical screwdriver, reusable

tomas® - J011302004200

tomas® anchorage system: tomas®-applicator (manual screwing aid)
DENTAURUM GmbH & Co.KG
302-004-20
In Commercial Distribution

  • J011302004200 ()


  • Surgical screwdriver, reusable
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