Microscope Navigation

GUDID 04056481145828

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481145828
• NIH Device Record Key: 7cb9572e-5a96-4ad5-a3ff-932d5d910b8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microscope Navigation
• Version Model Number: 1.7
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481145828 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223288

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: 2025-06-19
• Device Publish Date: 2025-06-11

On-Brand Devices [Microscope Navigation ]

• 04056481142537: 1.6
• 04056481145828: 1.7