XRES

GUDID 08033178110846

SORIN GROUP ITALIA SRL

Medical device service rail clamp

• Primary Device ID: 08033178110846
• NIH Device Record Key: 1483eb2c-41c1-4f40-9024-babaeb3f61f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XRES
• Version Model Number: HOLDER
• Company DUNS: 442126587
• 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: true
• 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	08033178110846 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100507

FDA Product Code

• DTN: Reservoir, blood, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-01
• Device Publish Date: 2023-10-24

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