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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Apllon Dilator Ø14.0
ALPHANOX CO.,LTD.
4901-3005
In Commercial Distribution

  • 08806373526084 ()
4901-3005

  • External spinal fixation system
Apllon Dilator Ø9.7
ALPHANOX CO.,LTD.
4901-3004
In Commercial Distribution

  • 08806373526077 ()
4901-3004

  • External spinal fixation system
Apllon Dilator Ø5.7
ALPHANOX CO.,LTD.
4901-3003
In Commercial Distribution

  • 08806373526060 ()
4901-3003

  • External spinal fixation system
Torque Wrench
ALPHANOX CO.,LTD.
4901-2012
In Commercial Distribution

  • 08806373526015 ()
4901-2012

  • External spinal fixation system
Rod Holder
ALPHANOX CO.,LTD.
4901-2009
In Commercial Distribution

  • 08806373525988 ()
4901-2009

  • External spinal fixation system
Nut Screw Guide
ALPHANOX CO.,LTD.
4901-2008
In Commercial Distribution

  • 08806373525971 ()
4901-2008

  • External spinal fixation system
Anti-Torque Wrench
ALPHANOX CO.,LTD.
4901-2006
In Commercial Distribution

  • 08806373525957 ()
4901-2006

  • External spinal fixation system
Poly-Axial Screw Driver
ALPHANOX CO.,LTD.
4901-2002
In Commercial Distribution

  • 08806373525919 ()
4901-2002

  • Orthopaedic implant driver
Mono-Axial Screw Driver
ALPHANOX CO.,LTD.
4901-2001
In Commercial Distribution

  • 08806373525902 ()
4901-2001

  • Orthopaedic implant driver
Probe for Ø6.5mm Screw, Curved
ALPHANOX CO.,LTD.
4901-0041
In Commercial Distribution

  • 08806373525803 ()
4901-0041

  • External spinal fixation system
Screw Driver 3HEX
ALPHANOX CO.,LTD.
4901-0030
In Commercial Distribution

  • 08806373525704 ()
4901-0030

  • External spinal fixation system
Durameter Retractor
ALPHANOX CO.,LTD.
29-17014
In Commercial Distribution

  • 08806373512155 ()
29-17014

  • External spinal fixation system
  • Soft-tissue surgical hook, reusable
Rod Pusher
ALPHANOX CO.,LTD.
29-10026
In Commercial Distribution

  • 08806373510694 ()
29-10026

  • External spinal fixation system
Guide Pins, Ellipse
ALPHANOX CO.,LTD.
29-10016
In Commercial Distribution

  • 08806373510595 ()
29-10016

  • External spinal fixation system
Guide Pins, Triangle
ALPHANOX CO.,LTD.
29-10015
In Commercial Distribution

  • 08806373510588 ()
29-10015

  • External spinal fixation system
Pedicle Probe for 6.5mm Screw
ALPHANOX CO.,LTD.
29-10013
In Commercial Distribution

  • 08806373510564 ()
29-10013

  • External spinal fixation system
Pedicle Probe for 5.5mm Screw
ALPHANOX CO.,LTD.
29-10012
In Commercial Distribution

  • 08806373510557 ()
29-10012

  • External spinal fixation system
Hex Driver, 1/4" Square QC, 4.0, Spring Load
CTL Medical Corporation
015.7049
In Commercial Distribution

  • 00841732117846 ()


  • Internal spinal fixation procedure kit, reusable
Hex Driver, AO Male QC, Ramp Retention, 2.5
CTL Medical Corporation
100.7624
In Commercial Distribution

  • 00841732116894 ()


  • General internal orthopaedic fixation system implantation kit
Hex Driver MIS, 1/4" Square QC, 4.0, Ratcheting
CTL Medical Corporation
019.7050
In Commercial Distribution

  • 00841732113510 ()


  • Internal spinal fixation procedure kit, reusable
Hex Driver with Torque Limiting T-Handle, 5.0 (12 N-m)
CTL Medical Corporation
019.7063
In Commercial Distribution

  • 00841732109476 ()


  • Surgical screwdriver, reusable
Hex Driver, 1/4" Square QC, 5.0 with Shoulder
CTL Medical Corporation
019.7062
In Commercial Distribution

  • 00841732109469 ()


  • Surgical screwdriver, reusable
Hex Driver with Handle, 5.0 with Shoulder
CTL Medical Corporation
019.7061
In Commercial Distribution

  • 00841732109452 ()


  • Surgical screwdriver, reusable
Hex Driver, 1/4" Square QC, 4.0, Cannulated
CTL Medical Corporation
019.7041
In Commercial Distribution

  • 00841732109445 ()


  • Surgical screwdriver, reusable
Hex Driver with Torque Limiting T-Handle, 4.5
CTL Medical Corporation
016.7063
In Commercial Distribution

  • 00841732108981 ()


  • Surgical screwdriver, reusable
Hex Driver, Shaft, 1/4" Square Male QC, 4.5
CTL Medical Corporation
016.7062
In Commercial Distribution

  • 00841732108974 ()


  • Surgical screwdriver, reusable
Hex Driver with Handle, Self-Retention, 4.5
CTL Medical Corporation
016.7061
In Commercial Distribution

  • 00841732108967 ()


  • Surgical screwdriver, reusable
Hex Driver with Handle, 3.0
CTL Medical Corporation
016.7052
In Commercial Distribution

  • 00841732108950 ()


  • Surgical screwdriver, reusable
Hex Driver, Cannulated, 1/4" Square QC, 4.0 Self-Retention
CTL Medical Corporation
016.7100
In Commercial Distribution

  • 00841732108929 ()


  • Surgical screwdriver, reusable
Hex Driver, Cannulated, 1/4" Square Male QC, 4.0
CTL Medical Corporation
016.7041
In Commercial Distribution

  • 00841732108912 ()


  • Surgical screwdriver, reusable
Hex Driver, Hudson LG QC, 5.0
CTL Medical Corporation
015.7082
In Commercial Distribution

  • 00841732108059 ()


  • Internal spinal fixation procedure kit, reusable
Hex Driver with Handle, 5.0
CTL Medical Corporation
015.7081
In Commercial Distribution

  • 00841732108042 ()


  • Internal spinal fixation procedure kit, reusable
Hex Driver, Hudson LG, QC, 4.0
CTL Medical Corporation
015.7054
In Commercial Distribution

  • 00841732107939 ()


  • Internal spinal fixation procedure kit, reusable
Hex Driver, Hudson LG QC, 4.0, Cannulated
CTL Medical Corporation
015.7100
In Commercial Distribution

  • 00841732107922 ()


  • Internal spinal fixation procedure kit, reusable
Distraction Pin Driver
CTL Medical Corporation
013.7101
In Commercial Distribution

  • 00841732105607 ()


  • General internal orthopaedic fixation system implantation kit
Hex Socket Driver, 6.0
CTL Medical Corporation
012.7103
In Commercial Distribution

  • 00841732105010 ()


  • Surgical screwdriver, reusable
Driver, Torque Limiter, 3 N-m
CTL Medical Corporation
012.7072
In Commercial Distribution

  • 00841732104945 ()


  • Surgical screwdriver, reusable
Driver, Set Screw, Star
CTL Medical Corporation
012.7071
In Commercial Distribution

  • 00841732104938 ()


  • Surgical screwdriver, reusable
Driver, Screw
CTL Medical Corporation
012.7043
In Commercial Distribution

  • 00841732104815 ()


  • Surgical screwdriver, reusable
Driver, Reduction Screw
CTL Medical Corporation
012.7042
In Commercial Distribution

  • 00841732104808 ()


  • Surgical screwdriver, reusable
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