ACUITY™ Spiral

GUDID 00802526422980

Coronary venous Dexamethasone Acetate-eluting Unipolar Pace/Sense Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial pacing lead

• Primary Device ID: 00802526422980
• NIH Device Record Key: b5a89278-4cf6-4420-8af3-ed304c78ed87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACUITY™ Spiral
• Version Model Number: 4591
• 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: 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	00802526422980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P010012

FDA Product Code

• LWP: Implantable pulse generator, pacemaker (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: 2014-09-24

On-Brand Devices [ACUITY™ Spiral]

• 00802526423222: Coronary venous Dexamethasone Acetate-eluting Unipolar Pace/Sense Lead
• 00802526423109: Coronary venous Dexamethasone Acetate-eluting Unipolar Pace/Sense Lead
• 00802526422980: Coronary venous Dexamethasone Acetate-eluting Unipolar Pace/Sense Lead