HeartPrint HEAPR-01-002-01

GUDID 05420060346002

Heartprint medical model, SLA

Materialise NV

Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model

• Primary Device ID: 05420060346002
• NIH Device Record Key: ce7dc2aa-8f5e-46a3-a024-57c1dbc91520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartPrint
• Version Model Number: HEAPR-01-002-01
• Catalog Number: HEAPR-01-002-01
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	05420060346002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183105

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: 2021-03-02
• Device Publish Date: 2021-02-22

On-Brand Devices [HeartPrint]

• 05420060346019: Heartprint medical model, SLS
• 05420060346002: Heartprint medical model, SLA