CARBOMEDICS ANNULOFLEX

GUDID 08022057013644

SORIN GROUP ITALIA SRL

Mitral/tricuspid annuloplasty ring

• Primary Device ID: 08022057013644
• NIH Device Record Key: b2598a9f-2728-456a-a44f-94fbe9f29dda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARBOMEDICS ANNULOFLEX
• Version Model Number: AF-8
• Company DUNS: 428011907
• Company Name: SORIN GROUP ITALIA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	08022057013644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023185

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 ANNULOFLEX]

• 08022057013651: AF-8
• 08022057013644: AF-8
• 08022057013637: AF-8
• 08022057013620: AF-8
• 08022057013613: AF-8
• 08022057013606: AF-8