CARBOMEDICS STANDARD

GUDID 08022057012678

SORIN GROUP ITALIA SRL

Mitral bi-leaflet mechanical heart valve prosthesis

• Primary Device ID: 08022057012678
• NIH Device Record Key: 5b6c80b1-6a50-4b1a-b22d-29db87961aa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBOMEDICS STANDARD
• Version Model Number: M7
• 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	08022057012678 [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 STANDARD]

• 08022057012753: M7
• 08022057012746: M7
• 08022057012739: M7
• 08022057012722: M7
• 08022057012715: M7
• 08022057012708: M7
• 08022057012692: M7
• 08022057012685: M7
• 08022057012678: M7
• 08022057012661: A5
• 08022057012654: A5
• 08022057012647: A5
• 08022057012630: A5
• 08022057012623: A5
• 08022057012616: A5
• 08022057012609: A5
• 08022057012593: A5
• 08022057012586: A5