WayPoint™ Locator Pins 66-WP-LP

GUDID 10873263003388

WayPoint Locator Pins, 4x, nonsterile

FHC, INC.

Neurological stereotactic surgery system

• Primary Device ID: 10873263003388
• NIH Device Record Key: b8c4b075-b8df-4aa2-8100-4f44e7c2bef0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Locator Pins
• Version Model Number: 66-WP-LP-00338
• Catalog Number: 66-WP-LP
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 4
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003381 [Unit of Use]
GS1	10873263003388 [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

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[10873263003388]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-06-08
• Device Publish Date: 2016-09-17

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• 00873263009086 - Visualase Anchor Bolt Tools: 2025-03-18 Visualase Anchor Bolt Tools (1) Sterilization & Storage Tray (1) Anchor Bolt Driver (1) Anchor Bolt Driver Guide for Stealth Aut
• 00873263009093 - Visualase Sterilization & Storage Tray: 2025-03-18 Visualase Sterilization & Storage Tray (1) Sterilization & Storage Tray
• 00873263009109 - Visualase Anchor Bolt Driver: 2025-03-18 Visualase Anchor Bolt Driver (1) Anchor Bolt Driver
• 00873263009116 - Visualase Anchor Bolt Driver Guide: 2025-03-18 Visualase Anchor Bolt Driver Guide for CRW (1) Anchor Bolt Driver Guide for CRW Stereotactic System
• 00873263009123 - Visualase Anchor Bolt Driver Guide: 2025-03-18 Visualase Anchor Bolt Guide for Leksell (1) Anchor Bolt Driver Guide for Leksell Coordinate Frame
• 00873263009130 - Visualase Anchor Bolt Driver Guide: 2025-03-18 Visualase Anchor Bolt Driver Guide for ROSA ONE (1) Anchor Bolt Driver Guide for ROSA ONE Brain