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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 - 00817421020315

BONE SCREW - 2.0Ø x 4mm
XNAV TECHNOLOGIES LLC
P007461
In Commercial Distribution

  • 00817421020315 ()
  • 00817421020322 ()
  • 00817421022951 ()
P007461

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020292

EDENTULOUS CLIP - NO SPIKES
XNAV TECHNOLOGIES LLC
P007750
In Commercial Distribution

  • 00817421020292 ()
  • 00817421020308 ()
P007750

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020278

EDENTULOUS CLIP
XNAV TECHNOLOGIES LLC
P007749
In Commercial Distribution

  • 00817421020278 ()
  • 00817421020285 ()
P007749

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020261

EDENTULOUS KIT
XNAV TECHNOLOGIES LLC
P008819
In Commercial Distribution

  • 00817421020261 ()
P008819

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020254

STRAIGHT HANDPIECE CALIBRATION BIT
XNAV TECHNOLOGIES LLC
P009311
In Commercial Distribution

  • 00817421020254 ()
P009311

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020247

WRENCH
XNAV TECHNOLOGIES LLC
P009154
In Commercial Distribution

  • 00817421020247 ()
P009154

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020230

PROBE TOOL
XNAV TECHNOLOGIES LLC
P008886
In Commercial Distribution

  • 00817421020230 ()
P008886

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020223

SCREW DRIVER
XNAV TECHNOLOGIES LLC
P007842
In Commercial Distribution

  • 00817421020223 ()
P007842

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020216

TRACKER ARM - LEFT
XNAV TECHNOLOGIES LLC
P008802
Not in Commercial Distribution

  • 00817421020216 ()
P008802

  • Surgical planning/navigation-enhancement system

X-Guide - 00817421020209

TRACKER ARM - RIGHT
XNAV TECHNOLOGIES LLC
P008800
Not in Commercial Distribution

  • 00817421020209 ()
P008800

  • Surgical planning/navigation-enhancement system
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