Séguin™ SARP-34

GUDID 05415067044853

Annuloplasty Ring for Mitral Valve Repair

ST. JUDE MEDICAL, INC.

Mitral/tricuspid annuloplasty ring, open-surgery

• Primary Device ID: 05415067044853
• NIH Device Record Key: e0ad8dc9-db16-4f05-8ea9-32bbe0e88e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Séguin™
• Version Model Number: SARP-34
• Catalog Number: SARP-34
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• 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

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter
• Outer Diameter: 34 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734007535 [Previous]
GS1	05415067044853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092310

FDA Product Code

• KRH: RING, ANNULOPLASTY

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: 2024-03-12
• Device Publish Date: 2024-03-04

On-Brand Devices [Séguin™]

• 05415067041951: Annuloplasty Ring Sizer Set
• 05415067044914: Annuloplasty Ring
• 05415067044754: Annuloplasty Ring for Mitral Valve Repair
• 05415067044891: Annuloplasty Ring for Mitral Valve Repair
• 05415067044877: Annuloplasty Ring for Mitral Valve Repair
• 05415067044815: Annuloplasty Ring for Mitral Valve Repair
• 05415067044853: Annuloplasty Ring for Mitral Valve Repair