MEMO 3D RECHORD

GUDID 08022057015075

SORIN GROUP ITALIA SRL

Mitral/tricuspid annuloplasty ring

• Primary Device ID: 08022057015075
• NIH Device Record Key: cbd62f6e-9220-4072-8c34-f8b52e1d7b88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEMO 3D RECHORD
• Version Model Number: MRCS
• 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	08022057015075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142221

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: 4
• Public Version Date: 2021-02-05
• Device Publish Date: 2015-07-24

On-Brand Devices [MEMO 3D RECHORD]

• 08022057015129: MRCS
• 08022057015112: MRCS
• 08022057015105: MRCS
• 08022057015099: MRCS
• 08022057015082: MRCS
• 08022057015075: MRCS
• 08022057015068: MRCS
• 08022057015051: MRCS