Rigid Saddle Ring RSAR-30

GUDID 05415067044693

Rigid Saddle Ring

ST. JUDE MEDICAL, INC.

Mitral/tricuspid annuloplasty ring, open-surgery

• Primary Device ID: 05415067044693
• NIH Device Record Key: 53a3198f-818e-4808-a45a-0747b2604e16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rigid Saddle Ring
• Version Model Number: RSAR-30
• Catalog Number: RSAR-30
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• 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

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: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter
• Outer Diameter: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734009447 [Previous]
GS1	05415067044693 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042734

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 [Rigid Saddle Ring]

• 05415067044730: Rigid Saddle Ring
• 05415067044716: Rigid Saddle Ring
• 05415067044655: Rigid Saddle Ring
• 05415067044693: Rigid Saddle Ring