ENDOTAK RELIANCE® SG

GUDID 00802526531163

Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead Endocardial defibrillation lead

• Primary Device ID: 00802526531163
• NIH Device Record Key: 697f3a06-7a9f-4d43-a9f1-a960af0621a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOTAK RELIANCE® SG
• Version Model Number: 0182
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: 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	00802526531163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910073

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

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: 2014-09-24

On-Brand Devices [ENDOTAK RELIANCE® SG]

• 00802526531255: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526531248: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526531170: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526531163: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526531156: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526531149: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526431388: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526431371: Steroid-eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526373374: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526373282: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead