Vascutek Gelweave™ Vascular Grafts 7314108/8RM

GUDID 05037881160733

Vascutek Gelweave™ Vascular Grafts

VASCUTEK LTD

Synthetic vascular graft

• Primary Device ID: 05037881160733
• NIH Device Record Key: 41f38125-525e-468f-8e97-54a01c07f1d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vascutek Gelweave™ Vascular Grafts
• Version Model Number: 7314108/8RM
• Catalog Number: 7314108/8RM
• Company DUNS: 229053087
• Company Name: VASCUTEK LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 14 Millimeter
• Device Size Text, specify: 0
• Length: 300 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881160733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162794

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [Vascutek Gelweave™ Vascular Grafts]

• 05037881160757: Vascutek Gelweave™ Vascular Grafts
• 05037881160740: Vascutek Gelweave™ Vascular Grafts
• 05037881160733: Vascutek Gelweave™ Vascular Grafts
• 05037881160726: Vascutek Gelweave™ Vascular Grafts
• 05037881160702: Vascutek Gelweave™ Vascular Grafts