Johari Digital Healthcare Ltd.

GUDID 08908008085468

"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."

JOHARI DIGITAL HEALTHCARE LIMITED

Stereotactic neuronavigation/planning system

• Primary Device ID: 08908008085468
• NIH Device Record Key: 2a964ca5-adde-4060-ab5d-9e20ceb8a3b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Johari Digital Healthcare Ltd.
• Version Model Number: Zeta Cranial Navigation System
• Company DUNS: 675938472
• Company Name: JOHARI DIGITAL HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908008085468 [Primary]

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-02
• Device Publish Date: 2024-01-25

On-Brand Devices [Johari Digital Healthcare Ltd.]

• 08908008085314: Cranial Electrotherapy Stimulation(CES)
• 08908008085338: Use for symptomatic relief and management of chronic pain and/or as adjunctive treatment in the
• 08908008085345: truSculpt flex comprises a system console with touchscreen LCD and sixteen electrode handpieces,
• 08908008085352: truSculpt flex comprises a system console with touchscreen LCD and sixteen electrode handpieces,
• 08908008085369: MYOLIFT QT is a device based on true micro-current technology and one of the most advanced perso
• 08908008085383: STIM TENS is cranial electrotherapy device and it provides powerful, predictable, proven stress
• 08908008085376: 600 is the latest True Microcurrent machine designed for professional use. Delivering true inte
• 08908008085406: Mindgear is cranial electrotherapy device and it is indicated for use CES for the treatment of i
• 08908008085420: "This device is a clinical combination therapy of Ultrasound & Electrotherapy with an easy user
• 08908008085413: "This device is a clinical combination therapy of Ultrasound & Electrotherapy with an easy user
• 08908008085437: "MYOLIFT Triwave is a device based on true micro-current technology and one of the most advanced
• 08908008085444: Myolift 600+ delivers True Microcurrent for Facial Toning and Firming. Its gentle, non-invasive
• 08908008085451: truFlex comprises a system console with a touchscreen LCD and sixteen electrode handpieces, whi
• 08908008085468: "The Zeta Cranial Navigation System Is A Stereotaxic Image Guidance System Intended For The Spat