ExacTrac Vero

GUDID 04056481132446

Brainlab AG

Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner Radiological whole-body positioner

• Primary Device ID: 04056481132446
• NIH Device Record Key: 740cde0b-2a34-4102-8ba8-78459fe2a5cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExacTrac Vero
• Version Model Number: 3.5
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481132446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122451

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: 2016-12-19

On-Brand Devices [ExacTrac Vero]

• 04056481132446: 3.5
• 04056481000769: 3.6