CROWN PRT

GUDID 00896208000504

Livanova Canada Corp

Aortic heart valve bioprosthesis

• Primary Device ID: 00896208000504
• NIH Device Record Key: 1fb1832c-7ba4-4904-9ff9-f2dd59c7851d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CROWN PRT
• Version Model Number: CNA
• Company DUNS: 243661431
• Company Name: Livanova Canada Corp
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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	00896208000504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060038

FDA Product Code

• LWR: heart-valve, non-allograft tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2016-08-16

On-Brand Devices [CROWN PRT]

• 00896208000542: CNA
• 00896208000535: CNA
• 00896208000528: CNA
• 00896208000511: CNA
• 00896208000504: CNA