X-Guide

Basic Information

• Brand Name: X-Guide
• Primary DI: 00817421021787
• Version / Model: P011000
• Company Name: XNAV TECHNOLOGIES LLC
• Labeler DUNS: 026096247
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-03
• Public Version: 2
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: 7c9cb588-ac9b-49a7-a561-60a410dbb3a6

Device Description

X-GUIDE (115V)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PLV	Dental Stereotaxic Instrument	Dental	872.4120	2
QRY	Dental Navigation System	Dental	872.4120	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61496	Surgical planning/navigation-enhancement system	A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817421021787	GS1
Package	00817421022302	GS1	Crate	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]