CARBOMEDICS ANNULOFLO

GUDID 08022057013682

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

• Primary Device ID: 08022057013682
• NIH Device Record Key: 7b593486-ed8d-4ce3-8fb4-21ffa850f8db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBOMEDICS ANNULOFLO
• Version Model Number: AR-7
• 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	08022057013682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021051

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 [CARBOMEDICS ANNULOFLO]

• 08022057013712: AR-7
• 08022057013705: AR-7
• 08022057013699: AR-7
• 08022057013682: AR-7
• 08022057013675: AR-7
• 08022057013668: AR-7