GUDID 00802526489181

Suture Sleeves

BOSTON SCIENTIFIC CORPORATION

Pacing/defibrillation lead suture sleeve

• Primary Device ID: 00802526489181
• NIH Device Record Key: 7f3ce7c0-61a4-4ec4-ab32-97127e202501
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 6221
• 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: 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	00802526489181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P960004

FDA Product Code

• DTB: permanent pacemaker Electrode

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-11
• Device Publish Date: 2014-09-24

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