WayPoint™ Surgical Kit 66-WP-MR

GUDID 00873263001721

WayPoint Surgical Kit Contains: Anchor Hex Wrench - 66-WP-HW Burr Hole Entry Marker Tool & Bushing 66-MP-EM STar SteriSuite Case 6mm Standoff Wrench - 66-WP-SW WayPoint Driver Handle - 66-WP-DH Combination Driver Bit - 66-WP-CD microTargeting Sterilization Tray - 67-00-1

FHC, INC.

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 00873263001721
• NIH Device Record Key: dde21ac7-b7d8-4367-b7ad-678f7e6dbbd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Surgical Kit
• Version Model Number: 66-WP-MR-00317
• Catalog Number: 66-WP-MR
• Company DUNS: 108179458
• Company Name: FHC, INC.
• Device Count: 1
• DM Exempt: false
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius
• Storage Environment Temperature: Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263001721 [Direct Marking]
GS1	00873263003176 [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

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

Moist Heat or Steam Sterilization

[00873263001721]

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: 2016-09-17

On-Brand Devices [WayPoint™ Surgical Kit]

• 00873263001721: WayPoint Surgical Kit Contains: Anchor Hex Wrench - 66-WP-HW Burr Hole Entry Marker Tool & Bush
• 00873263003046: WayPoint Disposable Surgical Kit, sterile