neuromate - neuroinspire software 001.0123

GUDID 03662724000482

RENISHAW MAYFIELD

Neurological stereotactic surgery system

• Primary Device ID: 03662724000482
• NIH Device Record Key: 4994ef88-cff9-4922-89bc-bd787e180243
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neuromate - neuroinspire software
• Version Model Number: neuroinspire SW Atlas Module
• Catalog Number: 001.0123
• Company DUNS: 277433335
• Company Name: RENISHAW MAYFIELD
• 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: false
• 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	03662724000482 [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: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by RENISHAW MAYFIELD

• 03662724000390 - neuromate neuroinspire software: 2024-03-20
• 03662724000444 - neuromate planning station hardware: 2024-03-20
• 03662724000451 - Neuromate Planning Station Hardware: 2024-03-20
• 03662724000482 - neuromate - neuroinspire software: 2024-03-20
• 03662724000482 - neuromate - neuroinspire software: 2024-03-20
• 03662724000758 - neuromate planning station hardware: 2024-03-20
• 03662724000031 - neuromate tool-holder: 2022-04-08 The standard tool-holder is universal and features a guide bushing into which standard neurosurgical instruments may be inserted
• 03662724000055 - neuromate tool guide: 2022-04-08 Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is adapted.
• 03662724000079 - neuromate tool guide: 2022-04-08 Long tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter of the central hole is ada