Automatic Registration

GUDID 04056481145101

Trade names: AUTO-REGISTRATION SOFTWARE AIRO CRANIAL, AUTO-REGISTRATION SOFTWARE AIRO CMF, AUTO-REGISTRATION SOFTWARE LOOP-X CRANIAL, AUTO-REGISTRATION SOFTWARE LOOP-X CMF, AUTO-REGISTRATION SOFTWARE UNIVERSAL AIR CRANIAL, AUTO-REGISTRATION SOFTWARE UNIVERSAL AIR CMF,

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481145101
• NIH Device Record Key: 33d50b19-2b8e-4222-8b98-8e75ff2e8d85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automatic Registration
• Version Model Number: 2.6
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481145101 [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: 2023-10-02
• Device Publish Date: 2023-09-22

On-Brand Devices [Automatic Registration]

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