Memo 4D

GUDID 08022057015457

SORIN GROUP ITALIA SRL

Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery

• Primary Device ID: 08022057015457
• NIH Device Record Key: 9287551c-0c4c-4b3d-b555-89314c8e7d07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Memo 4D
• Version Model Number: 4DM
• Company DUNS: 428011907
• Company Name: SORIN GROUP ITALIA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	08022057015457 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180411

FDA Product Code

• KRH: RING, ANNULOPLASTY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-02-05
• Device Publish Date: 2018-05-21

On-Brand Devices [Memo 4D]

• 08022057015495: 4DM
• 08022057015488: 4DM
• 08022057015471: 4DM
• 08022057015464: 4DM
• 08022057015457: 4DM
• 08022057015440: 4DM
• 08022057015433: 4DM
• 08022057015426: 4DM
• 08022057015419: 4DM
• 08022057015402: 4DM