Identity
- Trade Name
- Johari Digital Healthcare Ltd. FDA UDI
- Generic Name
- Stereotactic neuronavigation/planning system FDA UDI
- Device Name
- "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." FDA UDI
- Model / Reference
- Zeta Cranial Navigation System FDA UDI
- 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." FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08908008085468 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Stereotactic neuronavigation/planning system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Stereotactic neuronavigation/planning system
Johari Digital Healthcare Ltd. by Syrma Johari Medtech Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Syrma Johari Medtech Limited
Sources (1)
- FDA UDI 2a964ca5-adde-4060-ab5d-9e20ceb8a3b5 33 fields · synced May 30, 2026