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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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TRUMATCH - 05420060380747

Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide

Amplion Care Assurance - 00850016398024

Alert Display Driver (ADD) - Configuration 2 (curved)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-2
Not in Commercial Distribution

  • 00850016398024 ()
D-ADD-X-2

  • Nurse call system

Amplion Care Assurance - 00850016398017

Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system

Accu-Joint - 00850044114009

Driver, T6 Torx X15TN SS
Accufix Surgical, Inc.
AJDH-T6-X15TN
In Commercial Distribution

  • 00850044114009 ()
AJDH-T6-X15TN

  • Surgical screwdriver, reusable

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

DynaBunion - 00850038154189

The MotoBAND™ CP DynaForce® MPJ Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws. Certain plates in the system are compatible with the MotoCLIP/DynaForce Superelastic Fixation System.
CROSSROADS EXTREMITY SYSTEMS
1500-4801
In Commercial Distribution

  • 00850038154189 ()
1500-4801

  • Surgical screwdriver, single-use
  • Surgical screwdriver, reusable
  • Orthopaedic prosthesis implantation positioning instrument, single-use

PMT CORPORATION - STEREOTACTIC - 00650551004905

GLOBUS EXCELSIUS GPS DRIVER BUSHING FOR 2.7MM AND 3.2MM DRILL, OVERALL LENGTH 46.5MM
PMT CORPORATION
2103-229
In Commercial Distribution

  • 00650551004905 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551004431

sEEG ANCHOR BOLT DRIVER for 2.2/2.4mm, Length 235mm
PMT CORPORATION
2103-236
In Commercial Distribution

  • 00650551004431 ()


  • Neurological stereotactic surgery system

HALO TRAUMA KIT - 00650551003861

TRAUMA KIT, 1211-1S SMALL SHORT RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, (2) 1201-43 3" SKULL PINS, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6SS1
In Commercial Distribution

  • 00650551003861 ()


  • Cervical spine immobilization system, single-use

PMT CORPORATION - STEREOTACTIC - 00650551003496

Globus Excelsius GPS Driver Bushing for 2.7 / 3.2mm DrilL
PMT CORPORATION
2103-233
In Commercial Distribution

  • 00650551003496 ()


  • Neurological stereotactic surgery system

PMT CORPORATION - 00650551002673

AUTOGUIDE BUSHING, 2.2MM DRILL, DRIVER
PMT CORPORATION
2103-221
In Commercial Distribution

  • 00650551002673 ()


  • Neurological stereotactic surgery system

Catamaran® SIJ Fusion System - 00850033676495

Driver, K-Wire, 7.5mm, Catamaran
TENON MEDICAL, INC.
40396
In Commercial Distribution

  • 00850033676495 ()
40396

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

Catamaran® SIJ Fusion System - 00850033676358

K-Wire Driver, Catamaran
TENON MEDICAL, INC.
40370
In Commercial Distribution

  • 00850033676358 ()
40370

  • Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated

HOLO - 00850028694701

HOLO SL Reduction Driver Lock Tube
Surgalign Spine Technologies, Inc.
154000150
In Commercial Distribution

  • 00850028694701 ()


  • Surgical screwdriver, reusable

HOLO - 00850028694688

HOLO Streamline Driver, Lock Tube
Surgalign Spine Technologies, Inc.
154000140
In Commercial Distribution

  • 00850028694688 ()


  • Surgical screwdriver, reusable

HOLO - 00850028694671

HOLO Streamline Driver, Open Cannulated
Surgalign Spine Technologies, Inc.
154000131
In Commercial Distribution

  • 00850028694671 ()


  • Surgical screwdriver, reusable

HOLO - 00850028694664

HOLO Streamline Driver, Solid
Surgalign Spine Technologies, Inc.
154000130
In Commercial Distribution

  • 00850028694664 ()


  • Surgical screwdriver, reusable

HOLO Portal - 00850028694121

HOLO Hex Driver, Sterile
Surgalign Spine Technologies, Inc.
154000056
In Commercial Distribution

  • 00850028694121 ()


  • Multi-purpose stereotactic surgery system

HOLO Portal - 00850028694114

Streamline MIS Driver, Nav
Surgalign Spine Technologies, Inc.
154000028
In Commercial Distribution

  • 00850028694114 ()


  • Surgical screwdriver, reusable

REMI Robotic Navigation System - 00850026574500

MIS Driver
Fusion Robotics, LLC
1061
In Commercial Distribution

  • 00850026574500 ()
1061

  • Surgical screwdriver, reusable

REMI Robotic Navigation System - 00850026574258

8mm Hex Driver, Reference Arm
Fusion Robotics, LLC
1066
In Commercial Distribution

  • 00850026574258 ()


  • Surgical screwdriver, reusable

REMI Robotic Navigation System - 00850026574234

Driver
Fusion Robotics, LLC
1060
In Commercial Distribution

  • 00850026574234 ()


  • Surgical screwdriver, reusable

REVCON - 00850041704104

Hex Driver, 2.0mm
Voom Medical Devices, Inc
VDR01000
In Commercial Distribution

  • 00850041704104 ()

  • Outer Diameter: 2 Millimeter
VDR01000

  • Surgical screwdriver, reusable

SI Screw Inserter Torque Driver - 00850040139334

No Description
SURGENTEC, LLC
SR16-6500
In Commercial Distribution

  • 00850040139334 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

PMT® CORPORATION HALO - 00650551044949

TORQUE DRIVER
PMT CORPORATION
1201-8
In Commercial Distribution

  • 00650551044949 ()
1201-8

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551044932

PRECISION TORQUE DRIVER
PMT CORPORATION
1201-7
In Commercial Distribution

  • 00650551044932 ()
1201-7

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551044918

DOUBLE ENDED TORQUE DRIVER BIT, FOR 1201-8 TORQUE WRENCH
PMT CORPORATION
1201-52
In Commercial Distribution

  • 00650551044918 ()
1201-52

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551044864

BALL ENDED TORQUE DRIVER BIT, FOR 1201-7 PRECISION TORQUE DRIVER
PMT CORPORATION
1201-44
In Commercial Distribution

  • 00650551044864 ()
1201-44

  • Cervical spine immobilization system, single-use

PMT® CORPORATION HALO - 00650551044819

DISPOSABLE TORQUE DRIVER
PMT CORPORATION
1201-25
In Commercial Distribution

  • 00650551044819 ()
1201-25

  • Cervical spine immobilization system, single-use

PMT CORPORATION - STEREOTACTIC - 00650551039969

sEEG BOLT DRIVER REDUCING TUBE
PMT CORPORATION
2103-96
In Commercial Distribution

  • 00650551039969 ()
2103-96

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039952

sEEG DEPTH ANCHOR BOLT DRIVER, FOR ANCHOR BOLT 2103-29-XX
PMT CORPORATION
2103-95
In Commercial Distribution

  • 00650551039952 ()
2103-95

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039945

BUSHING FOR DRIVER FOR ROSA ROBOT, FOR 2.1MM DRILL
PMT CORPORATION
2103-94
In Commercial Distribution

  • 00650551039945 ()
2103-94

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039938

sEEG ANCHOR BOLT DRIVER, FOR ANCHOR BOLT 2103-15-XX
PMT CORPORATION
2103-93
In Commercial Distribution

  • 00650551039938 ()

  • Length: 1 Inch
2103-93

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039884

LEKSELL-sEEG DRIVER LOWER GUIDE BUSHING, FOR 2.1MM DRILL
PMT CORPORATION
2103-88
In Commercial Distribution

  • 00650551039884 ()
2103-88

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039877

LEKSELL-sEEG DRIVER UPPER GUIDE BUSHING, FOR 2.1MM DRILL
PMT CORPORATION
2103-87
In Commercial Distribution

  • 00650551039877 ()
2103-87

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039730

DEPTH STOP FOR DEPTHALON ANCHOR BOLT DRIVER
PMT CORPORATION
2103-72
In Commercial Distribution

  • 00650551039730 ()
2103-72

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039723

STEALTH SYSTEM-sEEG DEPTH ANCHOR BOLT DRIVER BUSHING, FOR 2.1MM DRILL
PMT CORPORATION
2103-71
In Commercial Distribution

  • 00650551039723 ()
2103-71

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039679

DEPTH STOP FOR sEEG ANCHOR BOLT DRIVER, FOR 2.1MM DRILL
PMT CORPORATION
2103-68
In Commercial Distribution

  • 00650551039679 ()
2103-68

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039662

BUSHING FOR DRIVER FOR ROSA ROBOT, SHORT, FOR 2.1MM DRILL
PMT CORPORATION
2103-67
In Commercial Distribution

  • 00650551039662 ()
2103-67

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039655

DEPTH STOP FOR sEEG ANCHOR BOLT DRIVER, FOR 2.4MM DRILL
PMT CORPORATION
2103-66
In Commercial Distribution

  • 00650551039655 ()
2103-66

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039648

sEEG ANCHOR BOLT DRIVER, FOR 2.4MM DRILL
PMT CORPORATION
2103-65
In Commercial Distribution

  • 00650551039648 ()

  • Length: 1 Inch
2103-65

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039631

sEEG ANCHOR BOLT DRIVER BUSHING, FOR 2.1MM DRILL
PMT CORPORATION
2103-64
In Commercial Distribution

  • 00650551039631 ()
2103-64

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039419

STEALTH SYSTEM-sEEG DEPTH ANCHOR BOLT DRILL/DRIVER BUSHING, FOR 2.4MM DRILL
PMT CORPORATION
2103-42
In Commercial Distribution

  • 00650551039419 ()
2103-42

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039358

CRW-GUIDE BUSHING FOR sEEG ANCHOR BOLT DRILL/DRIVER, FOR 2.4MM DRILL
PMT CORPORATION
2103-36
In Commercial Distribution

  • 00650551039358 ()
2103-36

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551039334

sEEG DEPTH ANCHOR BOLT DRIVER, FOR ANCHOR BOLT 2103-15-XX
PMT CORPORATION
2103-34
In Commercial Distribution

  • 00650551039334 ()
2103-34

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551038757

LEKSELL-sEEG DRIVER LOWER GUIDE BUSHING, FOR 2.4MM DRILL
PMT CORPORATION
2103-108
In Commercial Distribution

  • 00650551038757 ()
2103-108

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551038740

LEKSELL-sEEG DRIVER UPPER GUIDE BUSHING, FOR 2.4MM DRILL
PMT CORPORATION
2103-107
In Commercial Distribution

  • 00650551038740 ()
2103-107

  • Neurological stereotactic surgery system

PMT CORPORATION - STEREOTACTIC - 00650551038696

ANCHOR BOLT DRIVER, FOR VERTEK AND BRAINLAB
PMT CORPORATION
2103-102
In Commercial Distribution

  • 00650551038696 ()
2103-102

  • Neurological stereotactic surgery system
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