ACUITY™ X4 Spiral S

GUDID 00802526524578

Pace/Sense Lead

BOSTON SCIENTIFIC CORPORATION

Endocardial pacing lead

• Primary Device ID: 00802526524578
• NIH Device Record Key: f55af214-106a-4a05-9f99-dfb141c562ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACUITY™ X4 Spiral S
• Version Model Number: 4675
• 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	00802526524578 [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: 5
• Public Version Date: 2019-10-11
• Device Publish Date: 2016-02-25

On-Brand Devices [ACUITY™ X4 Spiral S]

• 00802526524578: Pace/Sense Lead
• 00802526524554: Pace/Sense Lead