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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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Q Pedicle Instruments - 10888857552234

Q Threaded Screwdriver Quick-Connect
K2M, INC.
48113502
In Commercial Distribution

  • 10888857552234 ()
48113502

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857552067

Monoaxial Screwdriver Shaft
K2M, INC.
PRO-1232-04
In Commercial Distribution

  • 10888857552067 ()
PRO-1232-04

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857552050

Reduction Polyaxial Screwdriver
K2M, INC.
PRO-1232-03
In Commercial Distribution

  • 10888857552050 ()
PRO-1232-03

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857552043

Polyaxial Screwdriver Shaft
K2M, INC.
PRO-1232-02
In Commercial Distribution

  • 10888857552043 ()
PRO-1232-02

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857551848

Locking Screw Inserter
K2M, INC.
PRO-1227
In Commercial Distribution

  • 10888857551848 ()
PRO-1227

  • Surgical screwdriver, reusable

Oasys® - 10888857551824

Inserter
K2M, INC.
PRO-1222
In Commercial Distribution

  • 10888857551824 ()
PRO-1222

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857551749

Retaining Screwdriver
K2M, INC.
PRO-1204
In Commercial Distribution

  • 10888857551749 ()
PRO-1204

  • Surgical screwdriver, reusable

NAPA Access System - 10888857551640

Driver Size 25
K2M, INC.
8030-90204
In Commercial Distribution

  • 10888857551640 ()
8030-90204

  • Orthopaedic prosthesis implantation positioning instrument, reusable

NAPA Access System - 10888857551633

Fixation Pin Driver
K2M, INC.
8030-90203
In Commercial Distribution

  • 10888857551633 ()
8030-90203

  • Bone nail driver

YUKON OCT Spinal System - 10888857551404

Tapered Set Screw Inserter, Double Ended Size 15
K2M, INC.
PRO-1193
In Commercial Distribution

  • 10888857551404 ()
PRO-1193

  • Surgical screwdriver, reusable

MESA Spinal System - 10888857551169

Screwdriver Size 25
K2M, INC.
PRO-1209
In Commercial Distribution

  • 10888857551169 ()
PRO-1209

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857551107

Polyaxial Screw Inserter
K2M, INC.
PRO-1191
In Commercial Distribution

  • 10888857551107 ()
PRO-1191

  • Orthopaedic implant driver

YUKON OCT Spinal System - 10888857550896

Locking Screw Inserter
K2M, INC.
PRO-1135
In Commercial Distribution

  • 10888857550896 ()
PRO-1135

  • Surgical screwdriver, reusable

CHESAPEAKE® Stabilization System - 10888857550537

Universal Tapered Driver Size 20
K2M, INC.
PRO-1187-05
In Commercial Distribution

  • 10888857550537 ()
PRO-1187-05

  • Orthopaedic implant driver

K2M General Instruments - 10888857550308

Locking Screw Inserter
K2M, INC.
PRO-1186-04
In Commercial Distribution

  • 10888857550308 ()
PRO-1186-04

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857550292

Locking Screw Inserter, Short
K2M, INC.
PRO-1186-03
In Commercial Distribution

  • 10888857550292 ()
PRO-1186-03

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857550285

Locking Screw Inserter
K2M, INC.
PRO-1186-02
In Commercial Distribution

  • 10888857550285 ()
PRO-1186-02

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857550278

Locking Screw Inserter, Short
K2M, INC.
PRO-1186-01
In Commercial Distribution

  • 10888857550278 ()
PRO-1186-01

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857549869

Polyaxial Screwdriver, Locking
K2M, INC.
PRO-1154
In Commercial Distribution

  • 10888857549869 ()
PRO-1154

  • Surgical screwdriver, reusable

Neoss Implant System - 05060440335754

Insertion Handle - Large
Neoss AB
51191
In Commercial Distribution

  • 05060440335754 ()
51191

  • Surgical screwdriver, reusable

Quick-Start - 05060464140266

Quick-Start Screwdriver 3.5mm Hex, 2.0mm Cannulation
INNOVATE ORTHOPAEDICS LIMITED
10026
In Commercial Distribution

  • 05060464140266 ()

  • 3.5mm Hex Head, 2.0mm Cannulation
10026

  • Surgical screwdriver, 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

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

K2M General Instruments - 10888857527713

Driver
K2M, INC.
PRO-1091-02
In Commercial Distribution

  • 10888857527713 ()
PRO-1091-02

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Xia® 3 System - Serrato® - 10888857580374

Locking Screw Inserter
K2M, INC.
PRO-1370
In Commercial Distribution

  • 10888857580374 ()
PRO-1370

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857580213

Driver Shaft
K2M, INC.
PRO-1232-06
In Commercial Distribution

  • 10888857580213 ()
PRO-1232-06

  • Surgical screwdriver, reusable

PYRENEES® Cervical Plate System - 10888857580176

Tapered Driver Size 10
K2M, INC.
PRO-1400
In Commercial Distribution

  • 10888857580176 ()
PRO-1400

  • Orthopaedic prosthesis implantation positioning instrument, reusable

K2M General Instruments - 10888857579897

Forceps Rod Fork
K2M, INC.
PRO-1401
In Commercial Distribution

  • 10888857579897 ()
PRO-1401

  • Surgical screwdriver, reusable

EVEREST® Spinal System - 10888857579637

Driver, Height Adjustment Size 25
K2M, INC.
PRO-1378
In Commercial Distribution

  • 10888857579637 ()
PRO-1378

  • Orthopaedic prosthesis implantation positioning instrument, reusable

K2M General Instruments - 10888857563254

Screwdriver, Split Tip
K2M, INC.
PRO-1330
In Commercial Distribution

  • 10888857563254 ()
PRO-1330

  • Surgical screwdriver, reusable

YUKON OCT Spinal System - 10888857561595

Flex Shaft Tapered Driver Size 20
K2M, INC.
PRO-1218
In Commercial Distribution

  • 10888857561595 ()
PRO-1218

  • Surgical screwdriver, reusable

K2M General Instruments - 10888857561373

Self Retaining Screw Inserter
K2M, INC.
PRO-1318
In Commercial Distribution

  • 10888857561373 ()
PRO-1318

  • Orthopaedic implant driver

CHESAPEAKE Stabilization System - 10888857560444

Screwdriver, Split Tip Size 20
K2M, INC.
PRO-1313-01
In Commercial Distribution

  • 10888857560444 ()
PRO-1313-01

  • Surgical screwdriver, reusable

YUKON OCT Spinal System - 10888857560413

Locking Screw Inserter
K2M, INC.
PRO-1316
In Commercial Distribution

  • 10888857560413 ()
PRO-1316

  • Orthopaedic implant driver

CHESAPEAKE Stabilization System - 10888857560062

Universal Driver Size 20
K2M, INC.
PRO-1313-02
In Commercial Distribution

  • 10888857560062 ()
PRO-1313-02

  • Surgical screwdriver, reusable

OZARK Cervical Plate System - 10888857548602

Screw Driver w/ Thread
K2M, INC.
PRO-1156
In Commercial Distribution

  • 10888857548602 ()
PRO-1156

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Paul Banditt - D955PARTNYLON1

PAUL BANDITT, NYLON REPLACEMENT TIPS FOR " NYLON" MALLET, Per pair
Terlain Enterprises, Inc.
PARTNYLON
In Commercial Distribution

  • D955PARTNYLON1 ()


  • Surgical mallet

Paul Banditt - D955PARTMEAD1

PAUL BANDITT, REPLACEMENT TIPS FOR " MEAD" MALLET, Per pair
Terlain Enterprises, Inc.
PARTMEAD
In Commercial Distribution

  • D955PARTMEAD1 ()


  • Surgical mallet

Paul Banditt - D955MALNYLON1

PAUL BANDITT NYLON, NYLON TIPPED MALLET, 180GM HOLLOW HANDLE, 18CM
Terlain Enterprises, Inc.
MALNYLON
In Commercial Distribution

  • D955MALNYLON1 ()


  • Surgical mallet

Paul Banditt - D955MALMEAD1

PAUL BANDITT MEAD MALLET, 19CM, 320GM
Terlain Enterprises, Inc.
MALMEAD
In Commercial Distribution

  • D955MALMEAD1 ()


  • Surgical mallet

Paul Banditt - D955MALGARDNER1

PAUL BANDITT GARDNER MALLET, 14.5CM
Terlain Enterprises, Inc.
MALGARDNER
In Commercial Distribution

  • D955MALGARDNER1 ()


  • Surgical mallet

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 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

Medtronic Reusable Instruments - 00643169330856

SAS EX0113053 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX0113053
In Commercial Distribution

  • 00643169330856 ()


  • Orthopaedic implant driver
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