RadiStop™ C11177

GUDID 15414734050057

Compression Assist Device

ST. JUDE MEDICAL, INC.

Radial artery compression device

• Primary Device ID: 15414734050057
• NIH Device Record Key: de449ba9-3dfc-4721-a7f3-272324e655ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RadiStop™
• Version Model Number: C11177
• Catalog Number: C11177
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734050050 [Primary]
GS1	15414734050057 [Package]; Contains: 05414734050050; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• GAX: TOURNIQUET, NONPNEUMATIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-04-19

Devices Manufactured by ST. JUDE MEDICAL, INC.

• 05415067049414 - Entrant™: 2024-05-03 VR Implantable Cardioverter Defibrillator
• 05415067049421 - Gallant™: 2024-05-03 VR Implantable Cardioverter Defibrillator
• 05415067049469 - Entrant™: 2024-05-03 DR Implantable Cardioverter Defibrillator
• 05415067049476 - Gallant™: 2024-05-03 DR Implantable Cardioverter Defibrillator
• 05415067049513 - Entrant™: 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator
• 05415067049520 - Gallant™: 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator
• 05415067047700 - TriClip™: 2024-04-22 G4 Delivery System
• 05415067047724 - TriClip™: 2024-04-22 G4 Delivery System