WATCHMAN® M635WU24060

GUDID 08714729838234

Left Atrial Appendage Closure Device with Delivery System

BOSTON SCIENTIFIC CORPORATION

Cardiac occluder

• Primary Device ID: 08714729838234
• NIH Device Record Key: e4e0196a-c036-4586-8b9a-c7711dc3d3f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WATCHMAN®
• Version Model Number: M635WU24060
• Catalog Number: M635WU24060
• Company DUNS: 021717889
• 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: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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	08714729838234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130013

FDA Product Code

• NGV: System, appendage closure, left atrial

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: 2019-11-01
• Device Publish Date: 2015-03-20

On-Brand Devices [WATCHMAN®]

• 08714729838265: Left Atrial Appendage Closure Device with Delivery System
• 08714729838258: Left Atrial Appendage Closure Device with Delivery System
• 08714729838241: Left Atrial Appendage Closure Device with Delivery System
• 08714729838234: Left Atrial Appendage Closure Device with Delivery System
• 08714729838227: Left Atrial Appendage Closure Device with Delivery System