ExacTrac Dynamic

GUDID 04056481144609

Brainlab AG

Radiation therapy software

• Primary Device ID: 04056481144609
• NIH Device Record Key: 4af9f8bf-9c20-472c-baee-64079864ff34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExacTrac Dynamic
• Version Model Number: 2.0
• 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: 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	04056481144609 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240431

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2025-02-27
• Device Publish Date: 2025-02-19

On-Brand Devices [ExacTrac Dynamic ]

• 04056481142506: 1.0
• 04056481143978: 1.1
• 04056481144609: 2.0