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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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NeuViz 64 Multi-slice CT Scanner System - 06970167440022

No Description
Neusoft Medical Systems Co., Ltd.
NeuViz 64 In
In Commercial Distribution

  • 06970167440022 ()


  • Full-body CT system

TITAN™ - 10381780258667

Self-Retaining Drill Adaptor
Ascension Orthopedics, Inc.
ADP-0980-105-00
In Commercial Distribution

  • M269ADP0980105001 ()
  • 10381780258667 ()

  • 8.13 in L x .275 in dia


  • Orthopaedic implant-instrument extension adaptor, reusable

TITAN™ - 10381780258339

Hudson T-Handle
Ascension Orthopedics, Inc.
HDL-0926-002
In Commercial Distribution

  • M269HDL09260021 ()
  • 10381780258339 ()

  • 5.20 in L x 4.50 in W


  • Orthopaedic implant-instrument extension adaptor, reusable

TITAN™ - 10381780258315

The guidewire is used as a guide for placement or insertion of a device.
Ascension Orthopedics, Inc.
GDW-0926-001
In Commercial Distribution

  • M269GDW09260011 ()
  • 10381780258315 ()

  • 8.5 in L x .11 in dia


  • Orthopaedic guidewire, reusable

TITAN™ - 10381780258216

The Fin-Lock Drill Guide is used for precision and accuracy when drilling.
Ascension Orthopedics, Inc.
DRG-0926-001
In Commercial Distribution

  • M269DRG09260011 ()
  • 10381780258216 ()

  • 1.25 in L x .960 in W


  • Surgical drill guide, reusable

Integra® - 10381780248187

Integra® External Fixation System The punch is used for the half pin drill guide in the external fixation system.
Ascension Orthopedics, Inc.
12225020002
In Commercial Distribution

  • M269122250200021 ()
  • 10381780248187 ()

  • 5.245 in L x .176 in dia
12225020002

  • Surgical drill guide, reusable

Integra® - 10381780247999

Integra® External Fixation System The generic lid is the top part of the case which locks onto the base and keeps content inside.
Ascension Orthopedics, Inc.
12227006
In Commercial Distribution

  • M269122270061 ()
  • 10381780247999 ()

  • 21.61 in L x 11.10 in W
12227006

  • Instrument tray, reusable

Integra® - 10381780247968

Integra® Titanium Bone Wedge System The Cotton Wedge Trial Caddy Lid is the top part of the caddy which locked onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-1006-05
Not in Commercial Distribution

  • M269CSA1006051 ()
  • 10381780247968 ()

  • 6.584 in L x 3.19 in W
CSA100605

  • Instrument tray, reusable

Integra® - 10381780247944

Integra® Titanium Bone Wedge System The LCL Wedge Trial Caddy Lid is the top part of the caddy which locked onto the base and keeps content inside the base.
Ascension Orthopedics, Inc.
CSA-1006-03
Not in Commercial Distribution

  • M269CSA1006031 ()
  • 10381780247944 ()

  • 6.584 in L x 5.215 in W
CSA100603

  • Instrument tray, reusable

TruArch® Subtalar Implant System - 10381780247869

Integra® TruArch® The guide wire is used as a guide for placement or insertion of a device.
Ascension Orthopedics, Inc.
TW-1100
Not in Commercial Distribution

  • M269TW11001 ()
  • 10381780247869 ()

  • 9.0 in L x .063 in dia
TW-1100

  • Orthopaedic guidewire, reusable
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