Ultrasound Navigation

GUDID 04056481140137

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481140137
• NIH Device Record Key: 603015d5-44d0-4f63-8edc-d32c367ff279
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrasound Navigation
• Version Model Number: 1.0
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481140137 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-29
• Device Publish Date: 2018-10-29

On-Brand Devices [Ultrasound Navigation]

• 04056481140137: 1.0
• 04056481144630: Ultrasound Navigation 1.2 is software that runs on a Brainlab IGS platform or Brainlab navigatio