405516

GUDID 05415067042651

Vessel Dilator

ST. JUDE MEDICAL, INC.

Vascular dilator, single-use

• Primary Device ID: 05415067042651
• NIH Device Record Key: 1ae69875-9620-46a5-aeaf-3e760ce85b7e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 405516
• Catalog Number: 405516
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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

Device Dimensions

• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French
• Length: 19 Centimeter
• Catheter Gauge: 9 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734022262 [Previous]
GS1	05415067042651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894330

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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: 2022-02-24
• Device Publish Date: 2022-02-16

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067042934 - Regent™: 2025-01-20 Mechanical Heart Valve
• 05415067042958 - Regent™: 2025-01-20 Mechanical Heart Valve
• 05415067042972 - Masters Series™: 2025-01-20 HP Mechanical Heart Valve
• 05415067043016 - Masters Series™: 2025-01-20 Mechanical Heart Valve
• 05415067043030 - Masters Series™: 2025-01-20 Mechanical Heart Valve
• 05415067043054 - Masters Series™: 2025-01-20 Mechanical Heart Valve
• 05415067043139 - Masters Series™: 2025-01-20 Mechanical Heart Valve
• 05415067043153 - Masters Series™: 2025-01-20 Mechanical Heart Valve