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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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X-Guide - 00817421020896

X-Guide 2.3.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020896 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421020797

X-Guide System Software Version 2.3.0
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020797 ()
P008542

  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421020735

CALIBRATION DISC ASM - FRICTION GRIP
XNAV TECHNOLOGIES LLC
P010227
In Commercial Distribution

  • 00817421020735 ()
P010227

  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421020728

HANDPIECE CONNECTOR ASM. - BIEN AIR
XNAV TECHNOLOGIES LLC
P009350
In Commercial Distribution

  • 00817421020728 ()
P009350

  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421020711

COMPUTER MOUSE
XNAV TECHNOLOGIES LLC
P008697
In Commercial Distribution

  • 00817421020711 ()
P008697

  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421020599

KEYBOARD
XNAV TECHNOLOGIES LLC
P008696
In Commercial Distribution

  • 00817421020599 ()
P008696

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020575

OFFSET TRACKER ARM - RIGHT
XNAV TECHNOLOGIES LLC
P009587
In Commercial Distribution

  • 00817421020575 ()
P009587

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020568

OFFSET TRACKER ARM - LEFT
XNAV TECHNOLOGIES LLC
P009586
In Commercial Distribution

  • 00817421020568 ()
P009586

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020520

X-CLIP
XNAV TECHNOLOGIES LLC
P007665
In Commercial Distribution

  • 00817421020520 ()
  • 00817421020582 ()
  • 00817421020605 ()
P007665

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020513

BASELINE CALIBRATION PLATE
XNAV TECHNOLOGIES LLC
P008810
In Commercial Distribution

  • 00817421020513 ()
P008810

  • Surgical planning/navigation-enhancement system
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