Vascutek Gelweave™ Vascular Grafts 7312108/8RM

GUDID 05037881160702

Vascutek Gelweave™ Vascular Grafts

VASCUTEK LTD

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: 05037881160702
• NIH Device Record Key: 27933412-f466-4041-9f77-5be68b6de4fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vascutek Gelweave™ Vascular Grafts
• Version Model Number: 7312108/8RM
• Catalog Number: 7312108/8RM
• 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

• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 300 Millimeter
• Lumen/Inner Diameter: 12 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	05037881160702 [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