Automatic Registration

GUDID 04056481142414

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481142414
• NIH Device Record Key: 58bffa85-71d2-4341-a806-9848b2d55b22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automatic Registration
• Version Model Number: 2.5
• 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: true
• Manufacturing Date: true
• 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	04056481142414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192703

FDA Product Code

• HAW: Neurological Stereotaxic Instrument
• OLO: Orthopedic 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: 2021-01-28
• Device Publish Date: 2021-01-20

On-Brand Devices [Automatic Registration]

• 04056481142414: 2.5
• 04056481145101: Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-