SJM Tailor™ TAB-35

GUDID 05415067044617

Annuloplasty Band

ST. JUDE MEDICAL, INC.

Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery Mitral/tricuspid annuloplasty ring, open-surgery

• Primary Device ID: 05415067044617
• NIH Device Record Key: 0ec4a0b9-47b9-4a3d-8a1d-8b7e56446b79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SJM Tailor™
• Version Model Number: TAB-35
• Catalog Number: TAB-35
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter
• Outer Diameter: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734055727 [Previous]
GS1	05415067044617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022363

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: 2024-01-22
• Device Publish Date: 2024-01-12

On-Brand Devices [SJM Tailor™]

• 05414734055727: Annuloplasty Band
• 05414734055710: Annuloplasty Band
• 05414734055703: Annuloplasty Band
• 05414734055697: Annuloplasty Band
• 05414734055680: Annuloplasty Band
• 05414734055673: Annuloplasty Band
• 05414734010085: Annuloplasty Ring Sizer Set
• 05414734007726: ANNULOPLASTY RING
• 05414734007719: ANNULOPLASTY RING
• 05414734007702: ANNULOPLASTY RING
• 05414734007696: ANNULOPLASTY RING
• 05414734007689: Annuloplasty Ring
• 05414734007672: ANNULOPLASTY RING
• 05415067044617: Annuloplasty Band
• 05415067044556: Annuloplasty Band
• 05415067044532: Annuloplasty Band
• 05415067044518: Annuloplasty Band
• 05415067044495: Annuloplasty Ring
• 05415067044457: Annuloplasty Ring
• 05415067044396: Annuloplasty Ring