Cardioroot HEWROOT0032

GUDID 00384401013921

Cardioroot Woven Collagen Coated Vascular Graft

INTERVASCULAR SAS

Synthetic vascular graft

• Primary Device ID: 00384401013921
• NIH Device Record Key: 77c97be5-8488-42db-b129-7f933e7c0b20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardioroot
• Version Model Number: HEWROOT0032
• Catalog Number: HEWROOT0032
• 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

• Height: 15 Centimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter
• Lumen/Inner Diameter: 32 Millimeter
• Height: 15 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00384401013921 [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