Johari Digital Healthcare Ltd.

Basic Information

• Brand Name: Johari Digital Healthcare Ltd.
• Primary DI: 08908008085468
• Version / Model: Zeta Cranial Navigation System
• Company Name: JOHARI DIGITAL HEALTHCARE LIMITED
• Labeler DUNS: 675938472
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-25
• Public Version: 1
• Public Version Date: 2024-02-02
• Public Version Status: New
• Public Device Record Key: 2a964ca5-adde-4060-ab5d-9e20ceb8a3b5

Device Description

"The Zeta Cranial Navigation System Is A Stereotaxic Image Guidance System Intended For The Spatial Positioning And Orientation Of Neurosurgical Instruments Used By Surgeons. The Zeta Cranial Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites."

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: No
• 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
HAW	Neurological Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56641	Stereotactic neuronavigation/planning system	A mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the mean of a three-dimensional (3-D) optical positioning system (frameless stereotactic neuronavigation) to provide real-time relative positioning for the treatment probes and instruments. It is typically used by healthcare providers in psychiatry, neuropsychiatry, and neurology for preoperative planning, in particular for consecutive image-guided transcranial magnetic stimulation (TMS) treatment sessions.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08908008085468	GS1