Mimics Cardiac Planner Mimics Cardiac Planner TTVR

GUDID 05404028001035

Mimics Cardiac Planner TTVR

Materialise NV

CAD/CAM software

• Primary Device ID: 05404028001035
• NIH Device Record Key: c6b55842-ef7c-4835-bdd9-d6dd1880ad3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mimics Cardiac Planner
• Version Model Number: Mimics Cardiac Planner TTVR
• Catalog Number: Mimics Cardiac Planner TTVR
• Company DUNS: 373139427
• Company Name: Materialise NV
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05404028001035 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233217

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: 2025-12-23
• Device Publish Date: 2025-12-15

On-Brand Devices [Mimics Cardiac Planner]

• 05404028000571: Mimics Cardiac Planner
• 05404028000762: Mimics Cardiac Planner
• 05404028001035: Mimics Cardiac Planner TTVR