905-15

GUDID 05415067029805

Double-ended handle, 15mm sizer rings

ST. JUDE MEDICAL, INC.

Heart valve sizer, reusable

• Primary Device ID: 05415067029805
• NIH Device Record Key: f4da9a88-89c3-403b-bd91-5bef9edeb112
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 905-15
• Catalog Number: 905-15
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05415067029805 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

[05415067029805]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-11

Devices Manufactured by ST. JUDE MEDICAL, INC.

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• 05414734405591 - Brio™: 2025-06-19 LE Charging System
• 05415067032027 - Tendyne™: 2025-06-06 2 lb Weight
• 05415067032096 - Tendyne™: 2025-06-06 Stand
• 05415067032447 - Tendyne™: 2025-06-06 Mitral Valve
• 05415067032454 - Tendyne™: 2025-06-06 Mitral Valve
• 05415067032461 - Tendyne™: 2025-06-06 Mitral Valve