FINELINE® II EZ Sterox

GUDID 00802526265013

Sterox Bipolar IS-1 Atrial/Ventricular

BOSTON SCIENTIFIC CORPORATION

Endocardial pacing lead

• Primary Device ID: 00802526265013
• NIH Device Record Key: 0401122a-ba67-4ca7-b118-433ed2230582
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FINELINE® II EZ Sterox
• Version Model Number: 4472
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526265013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960004

FDA Product Code

• DTB: permanent pacemaker Electrode

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-31
• Device Publish Date: 2014-09-24

On-Brand Devices [FINELINE® II EZ Sterox]

• 00802526265143: Sterox Bipolar IS-1 Atrial/Ventricular
• 00802526265037: Sterox Bipolar IS-1 Atrial/Ventricular
• 00802526265020: Sterox Bipolar IS-1 Atrial/Ventricular
• 00802526265013: Sterox Bipolar IS-1 Atrial/Ventricular
• 00802526265006: Sterox Bipolar IS-1 Atrial/Ventricular
• 00802526264993: Sterox Bipolar IS-1 Atrial/Ventricular