WayPoint™ Standoff Wrench 66-WP-SW

GUDID 00873263006030

microTargeting WayPoint Standoff Tool/Wrench, 1x, nonsterile, for use with STar Drive

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263006030
• NIH Device Record Key: a33f9416-75f9-4499-8861-c0a8cdf72259
• Commercial Distribution Discontinuation: 2018-12-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: WayPoint™ Standoff Wrench
• Version Model Number: 66-WP-SW-00603
• Catalog Number: 66-WP-SW
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263006030 [Primary]
GS1	00873263007105 [Direct Marking]

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

[00873263006030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-12-20
• Device Publish Date: 2017-07-21

On-Brand Devices [WayPoint™ Standoff Wrench]

• 00873263007297: microTargeting WayPoint Standoff Tool/Wrench, 1x, nonsterile, for use with STar Drive
• 00873263006030: microTargeting WayPoint Standoff Tool/Wrench, 1x, nonsterile, for use with STar Drive
• 00873263003510: microTargeting WayPoint Standoff Tool/Wrench, 1x, nonsterile, for use with STar Drive
• 00873263007280: microTargeting WayPoint Standoff Tool/Wrench, 1x, nonsterile, for use with STar Drive