X-GUIDE P008542

GUDID 00817421020797

X-Guide System Software Version 2.3.0

XNAV TECHNOLOGIES LLC

Surgical planning/navigation-enhancement system

• Primary Device ID: 00817421020797
• NIH Device Record Key: cc1d08ef-c532-4fc5-a563-14ab91b659de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-GUIDE
• Version Model Number: P008542
• Catalog Number: P008542
• Company DUNS: 026096247
• Company Name: XNAV TECHNOLOGIES LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 267-436-0414
• Email: fred.cowdery@x-navtech.com
• Phone: 267-436-0414
• Email: fred.cowdery@x-navtech.com
• Phone: 267-436-0414
• Email: fred.cowdery@x-navtech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817421020797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150222

FDA Product Code

• PLV: Dental Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-11
• Device Publish Date: 2019-01-11

On-Brand Devices [X-GUIDE]

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