XRES

GUDID 08033178110846

SORIN GROUP ITALIA SRL

Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp Medical device service rail clamp 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

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• 38033178018716 - Suction tip: 2024-04-12
• 38033178018723 - Suction tip: 2024-04-12
• 38033178018730 - Suction tip: 2024-04-12