LifeSpan ePTFE Vascular Graft R10080

GUDID 00840663105403

LifeSpan ePTFE Vascular Graft

LEMAITRE VASCULAR, INC.

Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft

• Primary Device ID: 00840663105403
• NIH Device Record Key: b346ac0f-be17-4cbb-a900-6c407fbd9647
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeSpan ePTFE Vascular Graft
• Version Model Number: R10080
• Catalog Number: R10080
• Company DUNS: 184805166
• Company Name: LEMAITRE VASCULAR, 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: true
• 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: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com
• Phone: 7812212266
• Email: csus@lemaitre.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840663105403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130016

FDA Product Code

• DSY: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-29

On-Brand Devices [ LifeSpan ePTFE Vascular Graft]

• 00840663105519: LifeSpan ePTFE Vascular Graft
• 00840663105403: LifeSpan ePTFE Vascular Graft
• 00840663105137: LifeSpan ePTFE Vascular Graft