CARBOMEDICS PROSTHETIC HEART VALVES

GUDID 08022057014030

SORIN GROUP ITALIA SRL

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