Gelsoft Plus Vascular Prostheses 632010P50E

GUDID 05037881167039

Gelsoft Plus Bifurcate

VASCUTEK LTD

Synthetic vascular graft

• Primary Device ID: 05037881167039
• NIH Device Record Key: 4c05021b-64c1-4db5-865a-fda3935f083e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gelsoft Plus Vascular Prostheses
• Version Model Number: 632010P50E
• Catalog Number: 632010P50E
• 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	05037881167039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241070

FDA Product Code

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

Sterilization

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

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

Ethylene Oxide

[05037881167039]

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 [Gelsoft Plus Vascular Prostheses]

• 05037881167046: Gelsoft Plus Bifurcate
• 05037881167039: Gelsoft Plus Bifurcate
• 05037881167022: Gelsoft Plus Bifurcate
• 05037881167008: Gelsoft Plus Bifurcate
• 05037881166995: Gelsoft Plus Bifurcate
• 05037881166971: Gelsoft Plus Bifurcate
• 05037881166940: Gelsoft Plus Bifurcate
• 05037881166933: Gelsoft Plus Bifurcate
• 05037881166926: Gelsoft Plus Bifurcate
• 05037881166902: Gelsoft Plus Straight
• 05037881166896: Gelsoft Plus Straight
• 05037881166889: Gelsoft Plus Straight
• 05037881166872: Gelsoft Plus Straight
• 05037881166865: Gelsoft Plus Straight
• 05037881166858: Gelsoft Plus Straight
• 05037881166841: Gelsoft Plus Straight
• 05037881166834: Gelsoft Plus Straight
• 05037881166810: Gelsoft Plus Straight
• 05037881166803: Gelsoft Plus Straight
• 05037881166797: Gelsoft Plus Straight
• 05037881166780: Gelsoft Plus Straight
• 05037881166742: Gelsoft Plus Straight
• 05037881166735: Gelsoft Plus Straight
• 05037881166728: Gelsoft Plus Straight
• 05037881166711: Gelsoft Plus Straight
• 05037881166698: Gelsoft Plus Straight
• 05037881166681: Gelsoft Plus Straight
• 05037881166674: Gelsoft Plus Straight
• 05037881166667: Gelsoft Plus Straight
• 05037881166650: Gelsoft Plus Straight
• 05037881166643: Gelsoft Plus Straight
• 05037881166636: Gelsoft Plus Straight
• 05037881166629: Gelsoft Plus Straight
• 05037881166612: Gelsoft Plus Straight
• 05037881166605: Gelsoft Plus Straight
• 05037881166551: Gelsoft Plus Straight
• 05037881166544: Gelsoft Plus Straight
• 05037881166537: Gelsoft Plus Straight
• 05037881166520: Gelsoft Plus Straight
• 05037881166063: Gelsoft Plus Straight