WayPoint™ Depth Stop 66-DS-MO

GUDID 00873263005446

WayPoint 1.8mm Depth Stop

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263005446
• NIH Device Record Key: 9ebc28e2-ae66-4b53-a8d5-652621c635c5
• Commercial Distribution Discontinuation: 2016-12-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WayPoint™ Depth Stop
• Version Model Number: 66-DS-MO-00544
• Catalog Number: 66-DS-MO
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Dimensions

• Lumen/Inner Diameter: 1.8 Millimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263005446 [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

[00873263005446]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-07

On-Brand Devices [WayPoint™ Depth Stop]

• 00873263005446: WayPoint 1.8mm Depth Stop
• 10873263005658: WayPoint 1.8mm Depth Stop