Cardioroot HEWROOT0024

GUDID 00384401013884

Cardioroot Woven Collagen Coated Vascular Graft

INTERVASCULAR SAS

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: 00384401013884
• NIH Device Record Key: f289f883-a8b0-48ef-9e5a-29aa55a0b738
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardioroot
• Version Model Number: HEWROOT0024
• Catalog Number: HEWROOT0024
• Company DUNS: 382174019
• Company Name: INTERVASCULAR SAS
• 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: true
• 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: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com
• Phone: +33442084646
• Email: cardiovascular.vics@getinge.com

Device Dimensions

• Length: 15 Centimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter
• Lumen/Inner Diameter: 24 Millimeter
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384401013884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103347

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: 2015-09-30

On-Brand Devices [Cardioroot]

• 00384401013938: Cardioroot Woven Collagen Coated Vascular Graft
• 00384401013921: Cardioroot Woven Collagen Coated Vascular Graft
• 00384401013914: Cardioroot Woven Collagen Coated Vascular Graft
• 00384401013907: Cardioroot Woven Collagen Coated Vascular Graft
• 00384401013891: Cardioroot Woven Collagen Coated Vascular Graft
• 00384401013884: Cardioroot Woven Collagen Coated Vascular Graft