WayPoint™ Surgical Kit 66-WP-SKS

GUDID 00873263003046

WayPoint Disposable Surgical Kit, sterile

FHC, INC.

Neurosurgical micro targeting drive

• Primary Device ID: 00873263003046
• NIH Device Record Key: 14db4eb2-9bf0-4920-b3a0-3cdf98bf4391
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WayPoint™ Surgical Kit
• Version Model Number: 66-WP-SKS-00304
• Catalog Number: 66-WP-SKS
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00873263003046 [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: true

[00873263003046]

Ethylene Oxide

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