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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 - 00817421020117

X-GUIDE TRAINING KIT
XNAV TECHNOLOGIES LLC
P008930
In Commercial Distribution

  • 00817421020117 ()
P008930

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020100

X-GUIDE USER MANUAL, ENGLISH
XNAV TECHNOLOGIES LLC
P007593
In Commercial Distribution

  • 00817421020100 ()
P007593

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020070

X-GUIDE REGION KIT - U.K. / IRELAND, ENGLISH
XNAV TECHNOLOGIES LLC
P009137
Not in Commercial Distribution

  • 00817421020070 ()
P009137

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020063

X-GUIDE REGION KIT - NORTH AMERICA, ENGLISH
XNAV TECHNOLOGIES LLC
P009081
In Commercial Distribution

  • 00817421020063 ()
P009081

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020056

CART TRAY KIT
XNAV TECHNOLOGIES LLC
P009186
In Commercial Distribution

  • 00817421020056 ()
P009186

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020025

X-GUIDE (United States)
XNAV TECHNOLOGIES LLC
P007839
In Commercial Distribution

  • 00817421020025 ()
  • 00817421022074 ()
P007839

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020018

X-GUIDE PLANNING SOFTWARE - MAC OS
XNAV TECHNOLOGIES LLC
P008526
In Commercial Distribution

  • 00817421020018 ()
P008526

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020001

X-GUIDE PLANNING SOFTWARE - MS WINDOWS
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020001 ()
P008296

  • Surgical planning/navigation-enhancement system

Welch Allyn, Inc. - 00817655023281

CONTROL STORAGE POLISH 220V
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00817655023281 ()
SCNODE-CGB-AXBXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00817655023274

Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; Polish language and CD m anual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and no display monitors; 0; Local storage for up to 600 days, no network printer included; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmia, 12-lead ST segment monitoring, and hemodynamic calculations (required for options with hard wired patient mo
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00817655023274 ()
SCSYS-IGD-ABFXX

  • Centralized patient monitor
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