Perceval RELYON PAK PAK-XL

GUDID 08022057015563

Perceval RELYON PAK Size XL

CORCYM SRL

Heart valve prosthesis holder, single-use

• Primary Device ID: 08022057015563
• NIH Device Record Key: 21bbad74-1b61-411d-b9ca-06f56b0c1301
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perceval RELYON PAK
• Version Model Number: PAK-XL
• Catalog Number: PAK-XL
• Company DUNS: 441454802
• Company Name: CORCYM SRL
• 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: true
• 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	08022057015563 [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: 2022-11-21
• Device Publish Date: 2022-11-11

On-Brand Devices [Perceval RELYON PAK ]

• 08022057015563: Perceval RELYON PAK Size XL
• 08022057015556: Perceval RELYON PAK Size L
• 08022057015549: Perceval RELYON PAK Size M
• 08022057015532: Perceval RELYON PAK Size S