neuromate tool guide 005.0804

GUDID 03662724000314

RENISHAW MAYFIELD

Neurological stereotactic surgery system

• Primary Device ID: 03662724000314
• NIH Device Record Key: 94654fa3-6d7c-4c1a-b824-5687d5722ce4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neuromate tool guide
• Version Model Number: Tool guide OD15 - Microdrive FHC microtargeting
• Catalog Number: 005.0804
• 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: true
• 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

Customer Support Contacts

• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx
• Phone: +33437238900
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	03662724000314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132755

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

[03662724000314]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-08
• Device Publish Date: 2016-12-22

On-Brand Devices [neuromate tool guide]

• 03662724000352: Tool guide OD15 - Monteris laser Ablation Kit
• 03662724000338: Tool guide OD15 - Standard guide with tool locking
• 03662724000321: Tool guide OD15 - Microdrive FHC stardrive - Lekse
• 03662724000314: Tool guide OD15 - Microdrive FHC microtargeting
• 03662724000079: Long tool adaptor or guide bushing to accommodate various diameters of instruments. Only the dia
• 03662724000055: Tool adaptor or guide bushing to accommodate various diameters of instruments. Only the diameter