TraumaCad Neo

GUDID 07290109943008

BRAINLAB LTD

Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software 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

Devices Manufactured by BRAINLAB LTD

• 07290109943008 - TraumaCad Neo: 2024-01-01
• 07290109943008 - TraumaCad Neo: 2024-01-01
• 07290109941004 - TraumaCad: 2018-09-24
• 07290109942001 - TraumaCad Mobile: 2018-09-24