Exactrac

GUDID 04056481006945

Brainlab AG

Radiological whole-body positioner

• Primary Device ID: 04056481006945
• NIH Device Record Key: 88e2d359-8ee4-4f6f-8002-df3eed6881c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exactrac
• Version Model Number: 48370
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481006945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120789

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-03-11
• Device Publish Date: 2018-02-09

On-Brand Devices [Exactrac]

• 04056481138400: 6.5
• 04056481006952: 48371
• 04056481006945: 48370
• 04056481000264: 6.2