ExacTrac Dynamic

GUDID 04056481143978

Brainlab AG

Radiation therapy software

• Primary Device ID: 04056481143978
• NIH Device Record Key: db4965fd-4d26-4313-b531-c9fa4b7143f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExacTrac Dynamic
• Version Model Number: 1.1
• 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: true
• 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	04056481143978 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220338

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: 2022-05-30
• Device Publish Date: 2022-05-20

On-Brand Devices [ExacTrac Dynamic]

• 04056481142506: 1.0
• 04056481143978: 1.1