Elements Trajectory Planning 26250-02C

GUDID 04056481000257

Brainlab AG

Robotic surgical navigation system

• Primary Device ID: 04056481000257
• NIH Device Record Key: f0bf21d4-db74-4a55-820b-a0d629d53c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elements Trajectory Planning
• Version Model Number: 2.0
• Catalog Number: 26250-02C
• 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
• Phone: +49899915680
• Email: contact@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056481000257 [Previous]
GS1	04056481138769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113732

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-19
• Device Publish Date: 2017-06-14

On-Brand Devices [Elements Trajectory Planning]

• 04056481140984: 2.5
• 04056481000257: 2.0