WayPoint™ Navigator

Basic Information

• Brand Name: WayPoint™ Navigator
• Primary DI: 00873263006993
• Version / Model: 66-WP-NV(4.5)-00699
• Catalog Number: 66-WP-NV(4.5)
• Company Name: FHC, INC.
• Labeler DUNS: 108179458
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-07
• Public Version: 2
• Public Version Date: 2020-03-30
• Public Version Status: Update
• Public Device Record Key: 67cea101-d2f9-4d59-b937-58492b812464

Device Description

WayPoint Navigator Workstation Version 4.5, 1x

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAW	Neurological stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00873263006993	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K092192	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius