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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 - 00817421021206

EDX-C TRACKER ARM, UPPER
XNAV TECHNOLOGIES LLC
P010860
In Commercial Distribution

  • 00817421021206 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021190

EDX-C TRACKER ARM, LOWER
XNAV TECHNOLOGIES LLC
P010857
In Commercial Distribution

  • 00817421021190 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021183

X-Guide 3.1.0 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421021183 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021114

TRACKER ARM ASSEMBLY, CLX, ANTERIOR LL
XNAV TECHNOLOGIES LLC
P010819
In Commercial Distribution

  • 00817421021114 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021107

TRACKER ARM ASSEMBLY, CLX, ANTERIOR LR
XNAV TECHNOLOGIES LLC
P010818
In Commercial Distribution

  • 00817421021107 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021091

TRACKER ARM ASSEMBLY, CLX, POSTERIOR LL
XNAV TECHNOLOGIES LLC
P010817
In Commercial Distribution

  • 00817421021091 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021084

TRACKER ARM ASSEMBLY, CLX, POSTERIOR LR
XNAV TECHNOLOGIES LLC
P010816
In Commercial Distribution

  • 00817421021084 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021077

TRACKER ARM ASSEMBLY, CLX, ANTERIOR UL
XNAV TECHNOLOGIES LLC
P010815
In Commercial Distribution

  • 00817421021077 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021060

TRACKER ARM ASSEMBLY, CLX, ANTERIOR UR
XNAV TECHNOLOGIES LLC
P010814
In Commercial Distribution

  • 00817421021060 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021053

TRACKER ARM ASSEMBLY, CLX, POSTERIOR UL
XNAV TECHNOLOGIES LLC
P010813
In Commercial Distribution

  • 00817421021053 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021046

TRACKER ARM ASSEMBLY, CLX, POSTERIOR UR
XNAV TECHNOLOGIES LLC
P010812
In Commercial Distribution

  • 00817421021046 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020995

X-MARK PROBE TOOL
XNAV TECHNOLOGIES LLC
P010673
In Commercial Distribution

  • 00817421020995 ()
P010673

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020988

LOANER PRACTICE KIT
XNAV TECHNOLOGIES LLC
P010670
In Commercial Distribution

  • 00817421020988 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020971

X-Guide 2.3.6 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020971 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020964

X-Guide 2.3.5 Linux Software
XNAV TECHNOLOGIES LLC
P008542
In Commercial Distribution

  • 00817421020964 ()


  • Surgical planning/navigation-enhancement system

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

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
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