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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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Ortho Solutions Extremity Fixation Implants for Osteosysnthesis - 05055662932768

AO QC COMPRESSION SCREW DRILL 22MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310206
In Commercial Distribution

  • 05055662932751 ()
  • 05055662932768 ()
OS310206

  • Cannulated surgical drill bit, single-use

Ortho Solutions Extremity Fixation Implants for Osteosysnthesis - 05055662932720

AO QC COMPRESSION SCREW DRILL 12MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310204
In Commercial Distribution

  • 05055662932713 ()
  • 05055662932720 ()
OS310204

  • Cannulated surgical drill bit, single-use

Ortho Solutions Extremity Fixation Implants for Osteosysnthesis - 05055662932706

AO QC COMPRESSION SCREW DRILL 18MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310203
In Commercial Distribution

  • 05055662932690 ()
  • 05055662932706 ()
OS310203

  • Cannulated surgical drill bit, single-use

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS - 05055662928952

SCARF SCREW DRIVER SHANK
ORTHO SOLUTIONS HOLDINGS LIMITED
OS320053
In Commercial Distribution

  • 05055662928952 ()
OS320053

  • Surgical screwdriver, reusable

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS - 05055662928884

WEIL SCREW SOLID DRIVER SHANK
ORTHO SOLUTIONS HOLDINGS LIMITED
OS319056
In Commercial Distribution

  • 05055662928884 ()
OS319056

  • Surgical screwdriver, reusable

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS - 05055662928877

2.3MM PHALANGEAL SCREW CANNULATED DRIVER SHANK
ORTHO SOLUTIONS HOLDINGS LIMITED
OS319054
In Commercial Distribution

  • 05055662928877 ()
OS319054

  • Surgical screwdriver, reusable

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM - 05055662928655

OXFORD/ OXBRIDGE AFN DRIVER
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333025
In Commercial Distribution

  • 05055662928655 ()
OS333025

  • Surgical screwdriver, reusable

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM - 05055662928594

OXFORD AFN SELF RETAINING SCREWDRIVER SHANK
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333020
In Commercial Distribution

  • 05055662928594 ()
OS333020

  • Surgical screwdriver, reusable

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS - 05055662928075

6.5/8.0 SCREWDRIVER SHANK
ORTHO SOLUTIONS HOLDINGS LIMITED
OS309005
In Commercial Distribution

  • 05055662928075 ()
OS309005

  • Surgical screwdriver, reusable

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS - 05055662923742

FPS 2.7MM TORX DRIVER
ORTHO SOLUTIONS HOLDINGS LIMITED
OS328003
In Commercial Distribution

  • 05055662923742 ()
OS328003

  • Surgical screwdriver, reusable

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS - 05055662923735

FPS 3.5MM CANNULATED HEXAGONAL SCREWDRIVER
ORTHO SOLUTIONS HOLDINGS LIMITED
OS328002
In Commercial Distribution

  • 05055662923735 ()
OS328002

  • Surgical screwdriver, reusable

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM - 05055662904932

6.5 MISS A NAIL SCREW DRIVER
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333526
In Commercial Distribution

  • 05055662904932 ()
OS333526

  • Surgical screwdriver, reusable

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM - 05055662944785

AFN MISS 5MM CANNULATED DRILL
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333525
In Commercial Distribution

  • 05055662944785 ()
OS333525

  • Cannulated surgical drill bit, single-use

ORTHO SOLUTIONS ULTOS PLATING SYSTEM - 05055662948523

UltOS 2.5MM HEX DRIVER CANNULATED AO QC
ORTHO SOLUTIONS HOLDINGS LIMITED
OS328027-NS
In Commercial Distribution

  • 05055662948523 ()
OS328027-NS

  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00643169066052

SCREWDRIVER EX0811453 LONG MAS LOCK
MEDTRONIC SOFAMOR DANEK, INC.
EX0811453
In Commercial Distribution

  • 00643169066052 ()


  • Orthopaedic implant driver

Anivia SG1000 Pump Console - 00850000067097

Pump Driver Module
APMTD, Inc.
SG1000-PDM-004
In Commercial Distribution

  • 00850000067097 ()
SG1000-PDM-004

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067080

Pump Driver Module
APMTD, Inc.
SG1000-PDM-003
In Commercial Distribution

  • 00850000067080 ()
SG1000-PDM-003

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067073

Pump Driver Module
APMTD, Inc.
SG1000-PDM-002
In Commercial Distribution

  • 00850000067073 ()
SG1000-PDM-002

  • Cardiopulmonary bypass system centrifugal pump drive unit

Anivia SG1000 Pump Console - 00850000067066

Pump Driver Module
APMTD, Inc.
SG1000-PDM-001
In Commercial Distribution

  • 00850000067066 ()
SG1000-PDM-001

  • Cardiopulmonary bypass system centrifugal pump drive unit

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

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

POWEREASE™ Instruments - 00643169007604

SLEEVE 2342402 LOCKING MPA SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
2342402
In Commercial Distribution

  • 00643169007604 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00643169007598

DRIVER 2342401 LOCKING MPA DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
2342401
In Commercial Distribution

  • 00643169007598 ()


  • Surgical screwdriver, reusable

Uniglide Unicondylar Knee Prosthesis - 05055196908123

C-ARM IMPACTOR
CORIN LTD
BC8K-2G01-000
In Commercial Distribution

  • 05055196908123 ()
BC8K-2G01-000

  • Orthopaedic implant driver

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis - 05055196905252

INTRODUCER LOCKING BAR
CORIN LTD
S279.843
In Commercial Distribution

  • 05055196905252 ()
S279.843

  • Surgical screwdriver, reusable

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis - 05055196901209

HAMMER
CORIN LTD
379.094
In Commercial Distribution

  • 05055196901209 ()
379.094

  • Surgical mallet

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis - 05055196901162

LOCKING SCREW WRENCH
CORIN LTD
379.126
In Commercial Distribution

  • 05055196901162 ()
379.126

  • Surgical screwdriver, reusable

Rotaglide+ Modular Knee System with Fixed Meniscus - 05055196901148

Locking screw wrench (T-handle)
CORIN LTD
379.123
In Commercial Distribution

  • 05055196901148 ()
379.123

  • Surgical screwdriver, reusable

Unity Total Knee System - 05055196901032

3.5 mm A/F Hex
CORIN LTD
279.018
In Commercial Distribution

  • 05055196901032 ()
279.018

  • Surgical screwdriver, reusable

ALEUTIAN® Interbody Systems - 10888857059283

Angled Lateral Inserter Driver, Size Driver
K2M, INC.
3201-90288
In Commercial Distribution

  • 10888857059283 ()
3201-90288

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ALEUTIAN® Interbody Systems - 10888857059221

Slap Hammer
K2M, INC.
3201-90267
In Commercial Distribution

  • 10888857059221 ()
3201-90267

  • Surgical mallet

ALEUTIAN® Interbody Systems - 10888857075610

Slap Hammer
K2M, INC.
3303-90052
In Commercial Distribution

  • 10888857075610 ()
3303-90052

  • Surgical mallet

ACTIVATION TOOL - 00848665010916

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
S0457
In Commercial Distribution

  • 00848665010916 ()


  • Surgical screwdriver, single-use

POWER CAPTURING ROD, SHORT 5.0mm - 00848665014235

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0492-100
In Commercial Distribution

  • 00848665014235 ()


  • Surgical screwdriver, reusable

POWER HEX SCREW DRIVER, SHORT 5.0mm - 00848665014228

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0491-100
In Commercial Distribution

  • 00848665014228 ()
0491-100

  • Surgical screwdriver, reusable

POWER HEX SCREW DRIVER 5.0mm - 00848665014204

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0488-100
In Commercial Distribution

  • 00848665014204 ()
0488-100

  • Surgical screwdriver, reusable
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