Reflexion Spiral™ 402804

GUDID 05414734206204

Bi-Directional Variable Radius Catheter

ST. JUDE MEDICAL, INC.

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 05414734206204
• NIH Device Record Key: 126feabb-cdfb-44fb-980f-3ec1c226f02b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reflexion Spiral™
• Version Model Number: 402804
• Catalog Number: 402804
• 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: true
• 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

Device Dimensions

• Catheter Gauge: 7 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place. Do not use if package is damaged and protect from heat and radioactive sources.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734206204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062251

FDA Product Code

• DRF: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-03-23

On-Brand Devices [Reflexion Spiral™]

• 05414734216654: D402893
• 05414734206204: Bi-Directional Variable Radius Catheter