Coronary Sinus Cannula

GUDID 38033178018105

SORIN GROUP ITALIA SRL

Coronary sinus cannula

• Primary Device ID: 38033178018105
• NIH Device Record Key: 24fe64dc-263c-473b-b624-9cc55c391cf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coronary Sinus Cannula
• Version Model Number: RCM-14815
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	08033178018104 [Primary]
GS1	38033178018105 [Package]; Contains: 08033178018104; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010974

FDA Product Code

• DWF: Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-19
• Device Publish Date: 2026-02-11

On-Brand Devices [Coronary Sinus Cannula]

• 38033178018105: RCM-14815
• 38033178018099: RCM-14315
• 38033178018075: RCM-14115