RELIANCE 4-FRONT™

GUDID 00802526592843

Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial defibrillation lead

• Primary Device ID: 00802526592843
• NIH Device Record Key: 3daf614c-0ec2-4094-b389-ffab9c9bd2d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIANCE 4-FRONT™
• Version Model Number: 0650
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526592843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910073

FDA Product Code

• NVY: Permanent defibrillator electrodes

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: 2019-10-09
• Device Publish Date: 2018-08-25

On-Brand Devices [RELIANCE 4-FRONT™]

• 00802526592874: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526592867: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526592850: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526592843: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526592836: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526592829: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526592812: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526592805: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526497001: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526496981: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526496967: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526496868: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead