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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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INTREPED, Intraosseous Fusion Device - 00850055649163

INTREPED 09 Driver
Auxano Medical LLC
01-40209
In Commercial Distribution

  • 00850055649163 ()
01-40209

  • Orthopaedic bone screw (non-sliding)

INTREPED, Intraosseous Fusion Device - 00850055649156

INTREPED 06 Driver
Auxano Medical LLC
01-40206
In Commercial Distribution

  • 00850055649156 ()
01-40206

  • Orthopaedic bone screw (non-sliding)

EquiLOX Lumbar Expandable Cage - Square Cage Driver (AO connector) - 00850065741253

Square Cage Driver (AO connector)
CAPTIVA SPINE, INC.
CSE06-R-0500-86
In Commercial Distribution

  • 00850065741253 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver

EquiLOX Lumbar Expandable Cage - Slap Hammer (tuning fork style) - 00850065741239

Slap Hammer (tuning fork style)
CAPTIVA SPINE, INC.
CSE06-R-1000-29
In Commercial Distribution

  • 00850065741239 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Hammer power shaft - 00850065741055

Hammer power shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-26
In Commercial Distribution

  • 00850065741055 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Hammer connecting shaft - 00850065741048

Hammer connecting shaft
CAPTIVA SPINE, INC.
CSE06-R-0500-28
In Commercial Distribution

  • 00850065741048 ()


  • Surgical mallet

EquiLOX Lumbar Expandable Cage - Square Cage Driver - 00850065741031

Square Cage Driver
CAPTIVA SPINE, INC.
CSE06-R-0500-48
In Commercial Distribution

  • 00850065741031 ()


  • Surgical implant/trial-implant/sizer holder, reusable
  • Orthopaedic implant driver

Flex - 00850190004674

Needle Driver
MEDROBOTICS CORPORATION
50474
In Commercial Distribution

  • 00850190004674 ()


  • Laparoscopic blunt dissector

CrossRoads Screw System - 00850310006892

The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
6.5 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006892 ()
1456-6565

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical screwdriver, single-use
  • Surgical depth gauge, single-use
  • Orthopaedic intraoperative positioning pin, single-use

CrossRoads Screw System - 00850310006878

The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
3.0 Headless Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006878 ()
1456-1408

  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Orthopaedic intraoperative positioning pin, single-use

CrossRoads Screw System - 00850310006854

The CrossRoads Screw System is indicated for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the device.
CROSSROADS EXTREMITY SYSTEMS
3.0 Headed Implant Prep Kit Including Reamer
In Commercial Distribution

  • 00850310006854 ()
1456-3030

  • Surgical depth gauge, single-use
  • Surgical screwdriver, single-use
  • Surgical countersink, single-use
  • Surgical instrument handle, non-torque-limiting
  • Fluted surgical drill bit, single-use
  • Orthopaedic intraoperative positioning pin, single-use

CrossTIE™ - 00850310006489

Intraosseous Fixation Implant to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
Inserter
In Commercial Distribution

  • 00850310006489 ()

  • Driver for 3.0mm CrossTIE Implant
4200-0000

  • Orthopaedic implant driver

CrossRoads™ Bone Screw - 00850310006410

CrossRoads™ Bone Screw System is used for fracture repair and fixation, osteotomy, joint fusion, reconstruction and arthrodesis of bones appropriate for the size of the bone screw.
CROSSROADS EXTREMITY SYSTEMS
Snap-Off Driver - Sterile
In Commercial Distribution

  • 00850310006410 ()
1456-0026

  • Surgical screwdriver, single-use

CrossTIE™ 2.0mm Hex Driver Cannulated - 00850310006397

Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1456-0018
In Commercial Distribution

  • 00850310006397 ()
1456-0018

  • Orthopaedic inorganic implant inserter/extractor, reusable

CrossTIE™ H10 Driver Cannulated - 00850310006380

Intraosseous Fixation System to aid in fixation of fractures, fusions, and osteotomies of the toes, such as hammertoe, claw toe, mallet toe and inter-digital fusions.
CROSSROADS EXTREMITY SYSTEMS
1456-0015
In Commercial Distribution

  • 00850310006380 ()
1456-0015

  • Orthopaedic inorganic implant inserter/extractor, reusable

Conformis Hip System - 00850268007552

3.5MM HEX U-JOINT DRIVER
Conformis, Inc.
1080-561
In Commercial Distribution

  • 00850268007552 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Conformis Hip System - 00850268007545

DRIVER, RIGID, 3.5MM HEX
Conformis, Inc.
1080-560
In Commercial Distribution

  • 00850268007545 ()

  • Outer Diameter: 3.5 Millimeter


  • Orthopaedic prosthesis implantation positioning instrument, reusable

SI-RESTORE - 00850073363294

SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300035
In Commercial Distribution

  • 00850073363294 ()


  • Surgical screwdriver, reusable

SI-RESTORE - 00850073363270

MALLET
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300031
In Commercial Distribution

  • 00850073363270 ()


  • Surgical mallet

SI-RESTORE - 00850073363218

SCREWDRIVER
BIOFUSION MANAGEMENT AND MANUFACTURING, LLC
1701-300017
In Commercial Distribution

  • 00850073363218 ()


  • Surgical screwdriver, reusable

SAM Medical - 00850068519033

SAM IO Driver
ZIEN MEDICAL TECHNOLOGIES, INC.
IO700
In Commercial Distribution

  • 10850068519030 ()
  • 00850068519033 ()


  • Intraosseous-access handpiece, infusion, manual

Wheelhouse Medical Specials - 00850058050102

No Description
Wheelhouse Medical
WM01-0112
In Commercial Distribution

  • 00850058050102 ()


  • Surgical screwdriver, reusable

Wheelhouse Medical Specials - 00850058050072

No Description
Wheelhouse Medical
WM01-0086
In Commercial Distribution

  • 00850058050072 ()


  • Surgical screwdriver, reusable

FORWARD IO INFUSION KIT - 00850056748018

FORWARD IO Infusion Kit with SAM IO Adaptor, SAM IO Driver, SAM IO 25mm Needle Assembly and SAM IO 45mm Assembly.
INTEGRATED MEDCRAFT LLC
1011-23000CB
In Commercial Distribution

  • 00850056748018 ()


  • Intraosseous infusion kit

OnPoint Fixed Adapter with Driver Array - 00850051682478

Fixed Adapter with Driver Array
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682478 ()
IN0211301

  • Orthopaedic stereotactic surgery system

OnPoint Rotating Adapter with Driver Array - 00850051682195

Rotating Adapter with Driver Array
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682195 ()
IN0211701

  • Orthopaedic stereotactic surgery system

OnPoint Hex Driver - 00850051682119

Hex Driver
OnPoint Surgical, Inc.
1
In Commercial Distribution

  • 00850051682119 ()
IN0210801

  • Orthopaedic stereotactic surgery system

STEREOTACTIC - 00650551148821

BUSHING FOR LEKSELL LOWER GUIDE BUSHING FOR 2.4MM DRILL/DRIVER, 83MM LENGTH
PMT CORPORATION
2103-206
In Commercial Distribution

  • 00650551148821 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551148784

SEEG ANCHOR BOLT DRIVER, 235MM LENGTH FOR 2.1MM DRILL
PMT CORPORATION
2103-204
In Commercial Distribution

  • 00650551148784 ()


  • Neurological stereotactic surgery system

STEREOTACTIC - 00650551148623

BRAINLAB/VERTEK BUSHING FOR 2.4MM DRILL/DRIVER, 70MM LENGTH
PMT CORPORATION
2103-203
In Commercial Distribution

  • 00650551148623 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551148616

SEEG ANCHOR BOLT DRIVER, 235MM LENGTH FOR 2.4MM DRILL
PMT CORPORATION
2103-202
In Commercial Distribution

  • 00650551148616 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551147503

SEEG DEPTH ANCHOR BOLT DRIVER WITH MEDIUM WELL SOCKET FOR 2.4MM DRILL
PMT CORPORATION
2103-144
In Commercial Distribution

  • 00650551147503 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551147480

BUSHING FOR 2.4MM DRIVER FOR NEUROMATE
PMT CORPORATION
2103-183
In Commercial Distribution

  • 00650551147480 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551146391

RULER, WITH SAME DIAMETER AS sEEG DRIVER, FOR 2.1MM DIAMETER DRILL BIT
PMT CORPORATION
2103-125
In Commercial Distribution

  • 00650551146391 ()
2103-125

  • Neurological stereotactic surgery system

DriverClip NBM - 00850043387367

DriverClip NBM. Clip recess underside of finger dental implant screwdriver with floss tether attachment. Resilient slide lock. Single use.
Implantwise LLC
NBM.
In Commercial Distribution

  • 00850043387367 ()


  • Surgical instrument interim-placement holder, single-use

DriverClip S - 00850043387350

DriverClip S. Clip recess underside of finger dental implant screwdriver with floss tether attachment. Single use only.
Implantwise LLC
S
In Commercial Distribution

  • 00850043387350 ()


  • Surgical instrument interim-placement holder, single-use

DriverClip Universal - 00850043387343

DriverClip Universal. Clip that goes through any orifice of a dental implant screwdriver with a floss tether attachment. Single use only.
Implantwise LLC
Universal
In Commercial Distribution

  • 00850043387343 ()


  • Surgical instrument interim-placement holder, single-use

Paradigm - 00850042604229

Mini Clamp Driver
Proprio, Inc.
1200019
In Commercial Distribution

  • 00850042604229 ()
1200019

  • Assistive gripping/twisting tool, reusable

INTREPED, Intraosseous Fusion Device - 00850055649415

INTREPED 10 Driver
Auxano Medical LLC
01-40210
In Commercial Distribution

  • 00850055649415 ()
01-40210

  • Orthopaedic bone screw (non-sliding)

INTREPED, Intraosseous Fusion Device - 00850055649408

INTREPED 08 Driver
Auxano Medical LLC
01-40208
In Commercial Distribution

  • 00850055649408 ()
01-40208

  • Orthopaedic bone screw (non-sliding)
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