LifeSpan ePTFE Vascular Graft R10080

GUDID 00840663105403

LifeSpan ePTFE Vascular Graft

LEMAITRE VASCULAR, INC.

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