Navigation Software Cranial 26615-01

GUDID 04056481138790

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481138790
• NIH Device Record Key: 650ddfb0-1216-47ad-b04e-e8cb405e9561
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navigation Software Cranial
• Version Model Number: 3.0
• Catalog Number: 26615-01
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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

Customer Support Contacts

• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com
• Phone: +18005975911
• Email: us.support@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481138790 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092467

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-30

On-Brand Devices [Navigation Software Cranial]

• 04056481140663: 3.5
• 04056481138790: 3.0