EMBLEM™ S-ICD

GUDID 00802526585968

Subcutaneous Electrode

BOSTON SCIENTIFIC CORPORATION

Endocardial defibrillation lead

• Primary Device ID: 00802526585968
• NIH Device Record Key: 61c8e21b-1ce2-49a3-9f65-02fb786e20f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBLEM™ S-ICD
• Version Model Number: 3401
• 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: false
• 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	00802526585968 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110042

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: 2016-08-17

On-Brand Devices [EMBLEM™ S-ICD]

• 00802526599200: Subcutaneous Electrode
• 00802526585968: Subcutaneous Electrode
• 00802526575600: Subcutaneous Electrode
• 00802526544101: Subcutaneous Implantable Cardioverter Defibrillator