GUDID 00802526067518

Lead Tunneler Kit

BOSTON SCIENTIFIC CORPORATION

Vascular graft tunneller

• Primary Device ID: 00802526067518
• NIH Device Record Key: 8c62e365-e871-4171-9b00-c0322f164d37
• Commercial Distribution Discontinuation: 2019-01-29
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 6888
• 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: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00802526067518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P830060

FDA Product Code

• LWP: Implantable pulse generator, pacemaker (non-CRT)

Sterilization

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

[00802526067518]

Moist Heat or Steam Sterilization;Ethylene Oxide

[00802526067518]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-15
• Device Publish Date: 2014-09-24

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