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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 - 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 - 00817421021589

ADAPTOR SLEEVE - 11
XNAV TECHNOLOGIES LLC
P010728
In Commercial Distribution

  • 00817421021589 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021572

ADAPTOR SLEEVE - 10
XNAV TECHNOLOGIES LLC
P010726
In Commercial Distribution

  • 00817421021572 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021565

ADAPTOR SLEEVE - 9
XNAV TECHNOLOGIES LLC
P010725
In Commercial Distribution

  • 00817421021565 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021558

ADAPTOR SLEEVE - 8
XNAV TECHNOLOGIES LLC
P010723
In Commercial Distribution

  • 00817421021558 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021541

ADAPTOR SLEEVE - 7
XNAV TECHNOLOGIES LLC
P010722
In Commercial Distribution

  • 00817421021541 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021534

ADAPTOR SLEEVE - 6
XNAV TECHNOLOGIES LLC
P010721
In Commercial Distribution

  • 00817421021534 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021527

ADAPTOR SLEEVE - 5
XNAV TECHNOLOGIES LLC
P010720
In Commercial Distribution

  • 00817421021527 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021510

ADAPTOR SLEEVE - 4
XNAV TECHNOLOGIES LLC
P010719
In Commercial Distribution

  • 00817421021510 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021503

ADAPTOR SLEEVE - 3
XNAV TECHNOLOGIES LLC
P010727
In Commercial Distribution

  • 00817421021503 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021497

ADAPTOR SLEEVE - 2
XNAV TECHNOLOGIES LLC
P010724
In Commercial Distribution

  • 00817421021497 ()


  • Surgical planning/navigation-enhancement system

X-GUIDE - 00817421021480

ADAPTOR SLEEVE - 1
XNAV TECHNOLOGIES LLC
P010701
In Commercial Distribution

  • 00817421021480 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021473

EDX Nut Driver
XNAV TECHNOLOGIES LLC
P010859
In Commercial Distribution

  • 00817421021473 ()
P010859

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021282

TRACKER ARM ASSEMBLY, EDX, ANTERIOR LL
XNAV TECHNOLOGIES LLC
P010876
In Commercial Distribution

  • 00817421021282 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021275

TRACKER ARM ASSEMBLY, EDX, ANTERIOR LR
XNAV TECHNOLOGIES LLC
P010875
In Commercial Distribution

  • 00817421021275 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021268

TRACKER ARM ASSEMBLY, EDX, POSTERIOR LL
XNAV TECHNOLOGIES LLC
P010874
Not in Commercial Distribution

  • 00817421021268 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021251

TRACKER ARM ASSEMBLY, EDX, POSTERIOR LR
XNAV TECHNOLOGIES LLC
P010873
Not in Commercial Distribution

  • 00817421021251 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021244

TRACKER ARM ASSEMBLY, EDX, ANTERIOR UL
XNAV TECHNOLOGIES LLC
P010872
In Commercial Distribution

  • 00817421021244 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021237

TRACKER ARM ASSEMBLY, EDX, ANTERIOR UR
XNAV TECHNOLOGIES LLC
P010871
In Commercial Distribution

  • 00817421021237 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021220

TRACKER ARM ASSEMBLY, EDX, POSTERIOR UL
XNAV TECHNOLOGIES LLC
P010870
Not in Commercial Distribution

  • 00817421021220 ()


  • Surgical planning/navigation-enhancement system

X-Guide - 00817421021213

TRACKER ARM ASSEMBLY, EDX, POSTERIOR UR
XNAV TECHNOLOGIES LLC
P010869
Not in Commercial Distribution

  • 00817421021213 ()


  • Surgical planning/navigation-enhancement system

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
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