CROWN PRT

GUDID 00896208000535

Livanova Canada Corp

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis

• Primary Device ID: 00896208000535
• NIH Device Record Key: c11b5e58-f659-4554-a211-ccba5760f94a
• 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	00896208000535 [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: 2016-08-08

On-Brand Devices [CROWN PRT]

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