EMBLEM™ S-ICD Electrode Delivery System

GUDID 00802526591907

Electrode Delivery System

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller Pacing/defibrillation lead tunneller

• Primary Device ID: 00802526591907
• NIH Device Record Key: 0993664e-3e6f-40ad-abbb-b76c716debe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBLEM™ S-ICD Electrode Delivery System
• Version Model Number: 4712
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00802526591907 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-29

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