PERCEVAL PLUS PVF-M

GUDID 08022057015372

SUTURELESS AORTIC HEART VALVE

CORCYM SRL

Aortic heart valve bioprosthesis

• Primary Device ID: 08022057015372
• NIH Device Record Key: 265d8d4b-a26c-42a7-95a9-f98131377b96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PERCEVAL PLUS
• Version Model Number: PVF-M
• Catalog Number: PVF-M
• Company DUNS: 441454802
• Company Name: CORCYM SRL
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	08022057015372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150011

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-15
• Device Publish Date: 2025-05-07

On-Brand Devices [PERCEVAL PLUS]

• 08022057015396: SUTURELESS AORTIC HEART VALVE
• 08022057015389: SUTURELESS AORTIC HEART VALVE
• 08022057015372: SUTURELESS AORTIC HEART VALVE
• 08022057015365: SUTURELESS AORTIC HEART VALVE