TraumaCad Neo

GUDID 07290109943008

BRAINLAB LTD

Radiological PACS software

• Primary Device ID: 07290109943008
• NIH Device Record Key: 5cfa8c69-6a89-431e-8756-bb967d99f538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TraumaCad Neo
• Version Model Number: 1.0
• Company DUNS: 533769907
• Company Name: BRAINLAB LTD
• 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

Customer Support Contacts

• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com
• Phone: +1 866 7170272
• Email: traumacad.support@brainlab.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290109943008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231498

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2024-01-01
• Device Publish Date: 2023-12-24

On-Brand Devices [TraumaCad Neo]

• 07290109943008: 1.0
• 07290109943015: 1.1