CARBOMEDICS OPTIFORM

GUDID 08022057012821

SORIN GROUP ITALIA SRL

Mitral bi-leaflet mechanical heart valve prosthesis

• Primary Device ID: 08022057012821
• NIH Device Record Key: e65738de-b24f-46b2-bf26-356b471b8767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBOMEDICS OPTIFORM
• Version Model Number: F7
• 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	08022057012821 [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 OPTIFORM]

• 08022057012883: F7
• 08022057012876: F7
• 08022057012869: F7
• 08022057012852: F7
• 08022057012845: F7
• 08022057012838: F7
• 08022057012821: F7