Tracker

Basic Information

• Brand Name: Tracker
• Primary DI: B435OKN1
• Version / Model: CUBE-OKN
• Company Name: WESTERN SYSTEMS RESEARCH INC.
• Labeler DUNS: 608365466
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-27
• Public Version: 1
• Public Version Date: 2023-07-05
• Public Version Status: New
• Public Device Record Key: 65fc0ef5-ac09-41dc-81a8-30d5abd0d537

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HOW	Drum, Opticokinetic	Ophthalmic	886.1200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16476	Nystagmus inducing optokinetic drum	A drum-like ophthalmic device covered with alternating white and dark stripes or pictures. The device is rotated in front of the patient's eyes and is intended to elicit nystagmus (involuntary rapid movement of the eyeball). This is used to diagnose the patient and is particularly useful for babies and children who cannot communicate, e.g., if nystagmus cannot be induced, this suggests that the child suffers from impaired vision or blindness.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B435OKN1	HIBCC