WayPoint™ Implantation Kit 66-WP-RU

GUDID 00873263007099

microTargeting WayPoint Implantation Kit, Reusable Components Contains: Sterilization Case Combination Bit WayPoint Driver 4mm

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 00873263007099
• NIH Device Record Key: 9a63bcf1-aa85-48af-bd64-a079940f4f28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Implantation Kit
• Version Model Number: 66-WP-RU-00708
• Catalog Number: 66-WP-RU
• 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	00873263007082 [Primary]
GS1	00873263007099 [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

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[00873263007099]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-30
• Device Publish Date: 2018-10-30

On-Brand Devices [WayPoint™ Implantation Kit]

• 00873263007099: microTargeting WayPoint Implantation Kit, Reusable Components Contains: Sterilization Case Comb
• 00873263005354: microTargeting WayPoint Implantation Kit, Reusable Components Contains: Sterilization Case Comb
• 00873263007082: microTargeting WayPoint Implantation Kit, Reusable Components Contains: Sterilization Case Comb