CARBOMEDICS

GUDID 08022057014016

SORIN GROUP ITALIA SRL

Heart valve prosthesis holder, reusable

• Primary Device ID: 08022057014016
• NIH Device Record Key: 01d7ed09-f6f9-4a89-8b21-74c6b4886334
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBOMEDICS
• Version Model Number: AR-150
• 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	08022057014016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P900060

FDA Product Code

• LWQ: HEART-VALVE, MECHANICAL

Sterilization

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

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

[08022057014016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-06-06

Devices Manufactured by SORIN GROUP ITALIA SRL

• 38033178004009 - Aortic-Root Cannula: 2025-04-17
• 38033178004016 - Aortic-Root Cannula: 2025-04-17
• 38033178004023 - Aortic-Root Cannula: 2025-04-17
• 38033178004030 - Aortic-Root Cannula: 2025-04-17
• 38033178004047 - Aortic-Root Cannula: 2025-04-17
• 38033178004054 - Aortic-Root Cannula: 2025-04-17
• 38033178114562 - MICRO: 2025-03-12
• 38033178114579 - MICRO: 2025-03-12