ACUITY™ Steerable

GUDID 00802526419324

Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial pacing lead

• Primary Device ID: 00802526419324
• NIH Device Record Key: b10c0b38-8057-4471-a59e-55a7c5c72d7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACUITY™ Steerable
• Version Model Number: 4554
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• 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

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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526419324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050046

FDA Product Code

• NVY: Permanent defibrillator electrodes

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: 2014-09-24

On-Brand Devices [ACUITY™ Steerable]

• 00802526419447: Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead
• 00802526419324: Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead