FINELINE® II EZ Sterox

GUDID 00802526265143

Sterox Bipolar IS-1 Atrial/Ventricular

BOSTON SCIENTIFIC CORPORATION

Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead Endocardial/interventricular septal pacing lead

• Primary Device ID: 00802526265143
• NIH Device Record Key: 90dd7821-f294-4720-905c-637774bad53e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FINELINE® II EZ Sterox
• Version Model Number: 4469
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526265143 [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