WayPoint™ Burr Hole Entry Marker Tool 66-MP-EM

GUDID 00873263001684

WayPoint Burr Hole Entry Marker Tool for use with microTargeting Platform

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263001684
• NIH Device Record Key: 431e25e7-1473-4051-bacd-b4a92eda1567
• Commercial Distribution Discontinuation: 2018-12-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WayPoint™ Burr Hole Entry Marker Tool
• Version Model Number: 66-MP-EM-00300
• Catalog Number: 66-MP-EM
• 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: 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: +1(800)326-2905
• Email: fhcinc@fh-co.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001684 [Direct Marking]
GS1	00873263003008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092192

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00873263001684]

Hydrogen Peroxide;Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-18
• Device Publish Date: 2016-09-17

On-Brand Devices [WayPoint™ Burr Hole Entry Marker Tool]

• 00873263007211: WayPoint Burr Hole Entry Marker Tool for use with microTargeting Platform
• 00873263001684: WayPoint Burr Hole Entry Marker Tool for use with microTargeting Platform
• 00873263007204: WayPoint Burr Hole Entry Marker Tool for use with microTargeting Platform