X-GUIDE P008542

GUDID 00817421020797

X-Guide System Software Version 2.3.0

XNAV TECHNOLOGIES LLC

Surgical planning/navigation-enhancement system
Primary Device ID00817421020797
NIH Device Record Keycc1d08ef-c532-4fc5-a563-14ab91b659de
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-GUIDE
Version Model NumberP008542
Catalog NumberP008542
Company DUNS026096247
Company NameXNAV TECHNOLOGIES LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone267-436-0414
Emailfred.cowdery@x-navtech.com
Phone267-436-0414
Emailfred.cowdery@x-navtech.com
Phone267-436-0414
Emailfred.cowdery@x-navtech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100817421020797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLVDental Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-11
Device Publish Date2019-01-11

On-Brand Devices [X-GUIDE]

00817421020797X-Guide System Software Version 2.3.0
00817421020735CALIBRATION DISC ASM - FRICTION GRIP
00817421020728HANDPIECE CONNECTOR ASM. - BIEN AIR
00817421020711COMPUTER MOUSE
00817421020599KEYBOARD
00817421020575OFFSET TRACKER ARM - RIGHT
00817421020568OFFSET TRACKER ARM - LEFT
00817421020520X-CLIP
00817421020513BASELINE CALIBRATION PLATE
00817421020506SAFETY GLASSES
00817421020490HANDPIECE CONNECTOR ASM. - W&H
00817421020483HANDPIECE CONNECTOR ASM. - NOUVAG
00817421020476HANDPIECE ASSEMBLY TOOL
00817421020452BONE SCREW - 2.7Ø x 10mm
00817421020438BONE SCREW - 2.7Ø x 8mm
00817421020414BONE SCREW - 2.7Ø x 6mm
00817421020391BONE SCREW - 2.7Ø x 4mm
00817421020377BONE SCREW - 2.0Ø x 10mm
00817421020353BONE SCREW - 2.0Ø x 8mm
00817421020339BONE SCREW - 2.0Ø x 6mm
00817421020315BONE SCREW - 2.0Ø x 4mm
00817421020292EDENTULOUS CLIP - NO SPIKES
00817421020278EDENTULOUS CLIP
00817421020261EDENTULOUS KIT
00817421020254STRAIGHT HANDPIECE CALIBRATION BIT
00817421020247WRENCH
00817421020230PROBE TOOL
00817421020223SCREW DRIVER
00817421020216TRACKER ARM - LEFT
00817421020209TRACKER ARM - RIGHT
00817421020193TRACKER ARM - UNIVERSAL
00817421020186HANDPIECE CALIBRATION DISC
00817421020179GO PLATE
00817421020162PATIENT TRACKER
00817421020155PROBE TOOL TRACKER
00817421020148HANDPIECE TRACKER
00817421020131INSTRUMENT KIT
00817421020124X-CLIP - PRACTICE
00817421020117X-GUIDE TRAINING KIT
00817421020100X-GUIDE USER MANUAL, ENGLISH
00817421020063X-GUIDE REGION KIT - NORTH AMERICA, ENGLISH
00817421020056CART TRAY KIT
00817421020025X-GUIDE (United States)
00817421020018X-GUIDE PLANNING SOFTWARE - MAC OS
00817421020001X-GUIDE PLANNING SOFTWARE - MS WINDOWS
00817421020988LOANER PRACTICE KIT
00817421020971X-Guide 2.3.6 Linux Software
00817421021183X-Guide 3.1.0 Linux Software
00817421020964X-Guide 2.3.5 Linux Software
00817421020896X-Guide 2.3.2 Linux Software

Trademark Results [X-GUIDE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
X-GUIDE
X-GUIDE
85925057 4896013 Live/Registered
X-Nav Technologies, LLC
2013-05-07

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