WATCHMAN® Access System M635TU10060

GUDID 08714729838197

Access Sheath with Dilator

BOSTON SCIENTIFIC CORPORATION

Cardiac occluder delivery kit

• Primary Device ID: 08714729838197
• NIH Device Record Key: 1c06a9b8-84c6-47d4-b10d-9548d11e3d08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WATCHMAN® Access System
• Version Model Number: M635TU10060
• Catalog Number: M635TU10060
• Company DUNS: 021717889
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729838197 [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: 2019-04-24
• Device Publish Date: 2015-03-20

On-Brand Devices [WATCHMAN® Access System]

• 08714729838210: Access Sheath with Dilator
• 08714729838203: Access Sheath with Dilator
• 08714729838197: Access Sheath with Dilator