WayPoint™ Hex Wrench 66-WP-HW

GUDID 00873263001752

WayPoint Hex Wrench

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263001752
• NIH Device Record Key: 946f6661-d3aa-4d31-90d3-318ecd842558
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Hex Wrench
• Version Model Number: 66-WP-HW-00331
• Catalog Number: 66-WP-HW
• 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
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com
• Phone: +1(800)326-2905
• Email: fhcinc@fh-co.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001752 [Direct Marking]
GS1	00873263003312 [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

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[00873263001752]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-09-17

On-Brand Devices [WayPoint™ Hex Wrench]

• 00873263001752: WayPoint Hex Wrench
• 00873263003312: WayPoint Hex Wrench