WayPoint™ Navigator C0240

GUDID 00873263007839

WayPoint Navigator - Laptop

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263007839
• NIH Device Record Key: e23fb4ee-5385-4a4e-9bce-599282f1f05a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Navigator
• Version Model Number: C0240-00783
• Catalog Number: C0240
• Company DUNS: 108179458
• Company Name: FHC, INC.
• 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: false
• Serial Number: true
• 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: +1(800)326-2905
• Email: fhcinc@fh-co.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263007839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092192

FDA Product Code

• HAW: Neurological 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: 2019-07-17
• Device Publish Date: 2019-07-09

On-Brand Devices [WayPoint™ Navigator]

• 00873263006993: WayPoint Navigator Workstation Version 4.5, 1x
• 00873263006139: WayPoint Navigator Workstation Version 4.4, 1X
• 00873263004333: microTargeting WayPoint Navigato, Laptop and Software, 1x
• 00873263007846: WayPoint Navigator - Standard License
• 00873263007839: WayPoint Navigator - Laptop
• 00873263007822: WayPoint ™ Navigator - Starter License
• 00873263007877: Waypoint™ Navigator -Academic License
• 00873263007860: Waypoint™ Navigator -Pay-per-use License
• 00873263007853: Waypoint™ Navigator - Enterprise License
• 00873263008140: WayPoint Navigator Workstation Version 4.6, 1x