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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 - 00817421022784

X-Guide 3.5.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022784 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022753

X-Guide 3.5.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022753 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022647

EDX-S Tracker Arm, Horizontal, Right
XNAV TECHNOLOGIES LLC
P010873
In Commercial Distribution

  • 00817421022647 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022630

EDX-S Tracker Arm, Vertical, Right
XNAV TECHNOLOGIES LLC
P010869
In Commercial Distribution

  • 00817421022630 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022623

EDX-S Tracker Arm, Horizontal, Left
XNAV TECHNOLOGIES LLC
P010874
In Commercial Distribution

  • 00817421022623 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022616

EDX-S Tracker Arm, Vertical, Left
XNAV TECHNOLOGIES LLC
P010870
In Commercial Distribution

  • 00817421022616 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022609

X-Guide 3.4.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022609 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022593

X-Guide 3.4.1 Windows Software
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421022593 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022500

WRENCH
XNAV TECHNOLOGIES LLC
P009154
In Commercial Distribution

  • 00817421022500 ()
P009154

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022418

X-Guide 3.4.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022418 ()


  • Surgical planning/navigation-enhancement system
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