Gel-Block™ 10x Embolization Pledgets

GUDID M20636401

Vascular Solutions, Inc.

Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived Non-neurovascular embolization plug, animal-derived

• Primary Device ID: M20636401
• NIH Device Record Key: a5e718dd-98ba-4e0e-823b-e37e2ef34419
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gel-Block™ 10x Embolization Pledgets
• Version Model Number: 3640
• Company DUNS: 008999906
• Company Name: Vascular Solutions, Inc.
• 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

Customer Support Contacts

• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com
• Phone: 888-240-6001
• Email: customerservice@vasc.com

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Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20636400 [Primary]
HIBCC	M20636401 [Package]; Contains: M20636400; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• KRD: Device, Vascular, For Promoting Embolization

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: 2021-02-05
• Device Publish Date: 2015-10-23

On-Brand Devices [Gel-Block™ 10x Embolization Pledgets]

• M20636421: 3642
• M20636411: 3641
• M20636401: 3640