ENDOTAK RELIANCE® S

GUDID 00802526085505

Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial defibrillation lead

• Primary Device ID: 00802526085505
• NIH Device Record Key: 4587705d-5146-40a6-ae0b-c2a37178f43f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOTAK RELIANCE® S
• Version Model Number: 0128
• 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	00802526085505 [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: 4
• Public Version Date: 2019-09-10
• Device Publish Date: 2014-09-24

On-Brand Devices [ENDOTAK RELIANCE® S]

• 00802526601835: Integrated Bipolar Pace/Sense and Defibrillation Lead
• 00802526601828: Integrated Bipolar Pace/Sense and Defibrillation Lead
• 00802526601811: Integrated Bipolar Pace/Sense and Defibrillation Lead
• 00802526601804: Integrated Bipolar Pace/Sense and Defibrillation Lead
• 00802526531118: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526531101: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead
• 00802526085505: Steroid-Eluting Bipolar Pace/Sense and Defibrillation Lead