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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BONE SCREW - 2.7Ø x 4mm
XNAV TECHNOLOGIES LLC
P007736
In Commercial Distribution

  • 00817421020391 ()
  • 00817421020407 ()
  • 00817421022999 ()
P007736

  • Surgical planning/navigation-enhancement system
BONE SCREW - 2.0Ø x 10mm
XNAV TECHNOLOGIES LLC
P007464
In Commercial Distribution

  • 00817421020377 ()
  • 00817421020384 ()
  • 00817421022982 ()
P007464

  • Surgical planning/navigation-enhancement system
BONE SCREW - 2.0Ø x 8mm
XNAV TECHNOLOGIES LLC
P007463
In Commercial Distribution

  • 00817421020353 ()
  • 00817421020360 ()
  • 00817421022975 ()
P007463

  • Surgical planning/navigation-enhancement system
BONE SCREW - 2.0Ø x 6mm
XNAV TECHNOLOGIES LLC
P007462
In Commercial Distribution

  • 00817421020339 ()
  • 00817421020346 ()
  • 00817421022968 ()
P007462

  • Surgical planning/navigation-enhancement system
BONE SCREW - 2.0Ø x 4mm
XNAV TECHNOLOGIES LLC
P007461
In Commercial Distribution

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

  • Surgical planning/navigation-enhancement system
EDENTULOUS CLIP - NO SPIKES
XNAV TECHNOLOGIES LLC
P007750
In Commercial Distribution

  • 00817421020292 ()
  • 00817421020308 ()
P007750

  • Surgical planning/navigation-enhancement system
EDENTULOUS CLIP
XNAV TECHNOLOGIES LLC
P007749
In Commercial Distribution

  • 00817421020278 ()
  • 00817421020285 ()
P007749

  • Surgical planning/navigation-enhancement system
EDENTULOUS KIT
XNAV TECHNOLOGIES LLC
P008819
In Commercial Distribution

  • 00817421020261 ()
P008819

  • Surgical planning/navigation-enhancement system
STRAIGHT HANDPIECE CALIBRATION BIT
XNAV TECHNOLOGIES LLC
P009311
In Commercial Distribution

  • 00817421020254 ()
P009311

  • Surgical planning/navigation-enhancement system
WRENCH
XNAV TECHNOLOGIES LLC
P009154
In Commercial Distribution

  • 00817421020247 ()
P009154

  • Surgical planning/navigation-enhancement system
PROBE TOOL
XNAV TECHNOLOGIES LLC
P008886
In Commercial Distribution

  • 00817421020230 ()
P008886

  • Surgical planning/navigation-enhancement system
SCREW DRIVER
XNAV TECHNOLOGIES LLC
P007842
In Commercial Distribution

  • 00817421020223 ()
P007842

  • Surgical planning/navigation-enhancement system
TRACKER ARM - LEFT
XNAV TECHNOLOGIES LLC
P008802
Not in Commercial Distribution

  • 00817421020216 ()
P008802

  • Surgical planning/navigation-enhancement system
TRACKER ARM - RIGHT
XNAV TECHNOLOGIES LLC
P008800
Not in Commercial Distribution

  • 00817421020209 ()
P008800

  • Surgical planning/navigation-enhancement system
TRACKER ARM - UNIVERSAL
XNAV TECHNOLOGIES LLC
P007505
In Commercial Distribution

  • 00817421020193 ()
P007505

  • Surgical planning/navigation-enhancement system
GO PLATE
XNAV TECHNOLOGIES LLC
P008641
In Commercial Distribution

  • 00817421020179 ()
P008641

  • Surgical planning/navigation-enhancement system
PATIENT TRACKER
XNAV TECHNOLOGIES LLC
P007652
In Commercial Distribution

  • 00817421020162 ()
P007652

  • Surgical planning/navigation-enhancement system
PROBE TOOL TRACKER
XNAV TECHNOLOGIES LLC
P009181
In Commercial Distribution

  • 00817421020155 ()
P009181

  • Surgical planning/navigation-enhancement system
HANDPIECE TRACKER
XNAV TECHNOLOGIES LLC
P007640
In Commercial Distribution

  • 00817421020148 ()
P007640

  • Surgical planning/navigation-enhancement system
INSTRUMENT KIT
XNAV TECHNOLOGIES LLC
P008818
In Commercial Distribution

  • 00817421020131 ()
P008818

  • Surgical planning/navigation-enhancement system
X-CLIP - PRACTICE
XNAV TECHNOLOGIES LLC
P007793
In Commercial Distribution

  • 00817421020124 ()
  • 00817421020544 ()
P007793

  • Surgical planning/navigation-enhancement system
X-GUIDE TRAINING KIT
XNAV TECHNOLOGIES LLC
P008930
In Commercial Distribution

  • 00817421020117 ()
P008930

  • Surgical planning/navigation-enhancement system
X-GUIDE USER MANUAL, ENGLISH
XNAV TECHNOLOGIES LLC
P007593
In Commercial Distribution

  • 00817421020100 ()
P007593

  • Surgical planning/navigation-enhancement system
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 REGION KIT - NORTH AMERICA, ENGLISH
XNAV TECHNOLOGIES LLC
P009081
In Commercial Distribution

  • 00817421020063 ()
P009081

  • Surgical planning/navigation-enhancement system
CART TRAY KIT
XNAV TECHNOLOGIES LLC
P009186
In Commercial Distribution

  • 00817421020056 ()
P009186

  • Surgical planning/navigation-enhancement system
X-GUIDE (United States)
XNAV TECHNOLOGIES LLC
P007839
In Commercial Distribution

  • 00817421020025 ()
  • 00817421022074 ()
P007839

  • Surgical planning/navigation-enhancement system
X-GUIDE PLANNING SOFTWARE - MAC OS
XNAV TECHNOLOGIES LLC
P008526
In Commercial Distribution

  • 00817421020018 ()
P008526

  • Surgical planning/navigation-enhancement system
X-GUIDE PLANNING SOFTWARE - MS WINDOWS
XNAV TECHNOLOGIES LLC
P008296
In Commercial Distribution

  • 00817421020001 ()
P008296

  • Surgical planning/navigation-enhancement system
ADAPTOR SLEEVE - 11
XNAV TECHNOLOGIES LLC
P010728
In Commercial Distribution

  • 00817421021589 ()


  • Surgical planning/navigation-enhancement system
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