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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 - 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

X-Guide - 00817421022296

X-Guide 3.3.4 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022296 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022067

X-Guide 3.3.2 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421022067 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022029

X-MARK UPGRADE KIT
XNAV TECHNOLOGIES LLC
P011211
In Commercial Distribution

  • 00817421022029 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421022012

X-Guide 3.3.1 Windows Software
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421022012 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021909

X-Guide 3.3.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021909 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021893

X-Guide 3.1.1 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021893 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021787

X-GUIDE (115V)
XNAV TECHNOLOGIES LLC
P011000
In Commercial Distribution

  • 00817421021787 ()
  • 00817421022302 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021619

HANDPIECE ADAPTOR NUT ASM
XNAV TECHNOLOGIES LLC
P010702
In Commercial Distribution

  • 00817421021619 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021602

ADAPTOR SLEEVE - 13
XNAV TECHNOLOGIES LLC
P010949
In Commercial Distribution

  • 00817421021602 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021596

ADAPTOR SLEEVE - 12
XNAV TECHNOLOGIES LLC
P010729
In Commercial Distribution

  • 00817421021596 ()


  • 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

X-Guide - 00817421020506

SAFETY GLASSES
XNAV TECHNOLOGIES LLC
P008395
In Commercial Distribution

  • 00817421020506 ()
P008395

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020490

HANDPIECE CONNECTOR ASM. - W&H
XNAV TECHNOLOGIES LLC
P008796
In Commercial Distribution

  • 00817421020490 ()
P008796

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020483

HANDPIECE CONNECTOR ASM. - NOUVAG
XNAV TECHNOLOGIES LLC
P007645
In Commercial Distribution

  • 00817421020483 ()
P007645

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020476

HANDPIECE ASSEMBLY TOOL
XNAV TECHNOLOGIES LLC
P009229
In Commercial Distribution

  • 00817421020476 ()
P009229

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020452

BONE SCREW - 2.7Ø x 10mm
XNAV TECHNOLOGIES LLC
P007739
In Commercial Distribution

  • 00817421020452 ()
  • 00817421020469 ()
  • 00817421023026 ()
P007739

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020438

BONE SCREW - 2.7Ø x 8mm
XNAV TECHNOLOGIES LLC
P007738
In Commercial Distribution

  • 00817421020438 ()
  • 00817421020445 ()
  • 00817421023019 ()
P007738

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020414

BONE SCREW - 2.7Ø x 6mm
XNAV TECHNOLOGIES LLC
P007737
In Commercial Distribution

  • 00817421020414 ()
  • 00817421020421 ()
  • 00817421023002 ()
P007737

  • Surgical planning/navigation-enhancement system
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