CARBOMEDICS SUPRA-ANNULAR (TOP HAT)

GUDID 08022057012937

SORIN GROUP ITALIA SRL

Aortic bi-leaflet mechanical heart valve prosthesis

• Primary Device ID: 08022057012937
• NIH Device Record Key: 27911022-abf4-4198-8258-b0f08d240872
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBOMEDICS SUPRA-ANNULAR (TOP HAT)
• Version Model Number: S5
• Company DUNS: 428011907
• Company Name: SORIN GROUP ITALIA 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: false
• 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	08022057012937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P900060

FDA Product Code

• LWQ: HEART-VALVE, MECHANICAL

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: 2014-07-23

On-Brand Devices [CARBOMEDICS SUPRA-ANNULAR (TOP HAT)]

• 08022057012937: S5
• 08022057012920: S5
• 08022057012913: S5
• 08022057012906: S5
• 08022057012890: S5