Gelweave Vascular Prostheses 735026E

GUDID 05037881168869

Gelweave Straight

VASCUTEK LTD

Synthetic vascular graft

• Primary Device ID: 05037881168869
• NIH Device Record Key: e83963cb-a2cf-4f12-a20a-6844754d57c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gelweave Vascular Prostheses
• Version Model Number: 735026E
• Catalog Number: 735026E
• Company DUNS: 229053087
• Company Name: VASCUTEK LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com
• Phone: +44441418125555
• Email: tmccustomer.admin@terumomedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881168869 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241550

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

[05037881168869]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-08
• Device Publish Date: 2025-03-31

On-Brand Devices [Gelweave Vascular Prostheses]

• 05037881176468: Gelweave W Arch
• 05037881176451: Gelweave W Arch
• 05037881176444: Gelweave W Arch
• 05037881176437: Gelweave W Arch
• 05037881176420: Gelweave Radial Plexus
• 05037881176413: Gelweave Radial Plexus
• 05037881176376: Gelweave Radial Plexus
• 05037881176369: Gelweave Radial Plexus
• 05037881176345: Gelweave Radial Plexus
• 05037881176314: Gelweave Radial Plexus
• 05037881176307: Gelweave Radial Plexus
• 05037881176291: Gelweave Radial Plexus
• 05037881176277: Gelweave Y Arch
• 05037881175409: Gelweave Double Bifurcate
• 05037881175379: Gelweave Bifurcate
• 05037881175362: Gelweave Bifurcate
• 05037881175348: Gelweave Bifurcate
• 05037881175331: Gelweave Bifurcate
• 05037881175317: Gelweave Bifurcate
• 05037881175300: Gelweave Bifurcate
• 05037881175294: Gelweave Bifurcate
• 05037881175287: Gelweave Trifurcate Side Branch
• 05037881175270: Gelweave Trifurcate Side Branch
• 05037881175263: Gelweave Trifurcate Side Branch
• 05037881175256: Gelweave Trifurcate Side Branch
• 05037881175232: Gelweave Trifurcate Arch
• 05037881175225: Gelweave Trifurcate Arch Side Branch Radiopaque
• 05037881175201: Gelweave Trifurcate Arch Side Branch Radiopaque
• 05037881175195: Gelweave Trifurcate Arch Side Branch Radiopaque
• 05037881175188: Gelweave Pre-Curved
• 05037881175157: Gelweave Trifurcate
• 05037881175140: Gelweave Pre-Curved
• 05037881175126: Gelweave Pre-Curved
• 05037881175102: Gelweave Pre-Curved
• 05037881175089: Gelweave Trifurcate
• 05037881175072: Gelweave Ante-Flo Pre-Curved
• 05037881175065: Gelweave Ante-Flo Pre-Curved
• 05037881175058: Gelweave Ante-Flo Pre-Curved
• 05037881175041: Gelweave Siena Ante-flo Pre-Curved Radiopaque
• 05037881175003: Gelweave Siena Ante-flo Pre-Curved Radiopaque
• 05037881174983: Gelweave Bifurcate
• 05037881174976: Gelweave Bifurcate
• 05037881174969: Gelweave Siena Ante-flo Pre-Curved Radiopaque
• 05037881174938: Gelweave Siena Ante-flo Pre-Curved Radiopaque
• 05037881174921: Gelweave Bifurcate
• 05037881174907: Gelweave Bifurcate
• 05037881174891: Gelweave Siena Ante-flo Pre-Curved Radiopaque
• 05037881174884: Gelweave Siena Ante-flo Pre-Curved Radiopaque
• 05037881174877: Gelweave Siena Ante-flo Pre-Curved Radiopaque
• 05037881174853: Gelweave Siena Ante-flo Pre-Curved Radiopaque