CARBOMEDICS PROSTHETIC HEART VALVES

GUDID 08022057014030

SORIN GROUP ITALIA SRL

Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle Heart valve prosthesis sizer handle

• Primary Device ID: 08022057014030
• NIH Device Record Key: 3f8c9e9d-416a-45cf-8e6a-c20815434b87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBOMEDICS PROSTHETIC HEART VALVES
• Version Model Number: RM-399
• Company DUNS: 428011907
• Company Name: SORIN GROUP ITALIA 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	08022057014030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951368

FDA Product Code

• MOP: Rotator, prosthetic heart valve

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

[08022057014030]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-12
• Device Publish Date: 2021-04-02

On-Brand Devices [CARBOMEDICS PROSTHETIC HEART VALVES]

• 08022057014030: RM-399
• 08022057014023: RH-100
• 08022057014009: TR-101
• 08022057013989: VH-100
• 08022057013965: VS2-1618
• 08022057013958: VS-200