Thoraflex™ Hybrid THA3032X100E

GUDID 05037881174174

Thoraflex Hybrid Ante-Flo

VASCUTEK LTD

Synthetic vascular graft

• Primary Device ID: 05037881174174
• NIH Device Record Key: 3552dab4-9b78-4c79-b2c0-37616498dcf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thoraflex™ Hybrid
• Version Model Number: THA3032X100E
• Catalog Number: THA3032X100E
• Company DUNS: 229053087
• Company Name: VASCUTEK LTD
• Device Count: 1
• DM Exempt: false
• 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: 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

Device Dimensions

• Stent Length: 100 Millimeter
• Stent Diameter: 32 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 32 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 32 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 32 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 32 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 32 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 32 Millimeter
• Stent Length: 100 Millimeter
• Stent Diameter: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05037881174174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P210006

FDA Product Code

• QSK: Hybrid stent graft, thoracic aortic lesion treatment

Sterilization

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

[05037881174174]

Ethylene Oxide

[05037881174174]

Ethylene Oxide

[05037881174174]

Ethylene Oxide

[05037881174174]

Ethylene Oxide

[05037881174174]

Ethylene Oxide

[05037881174174]

Ethylene Oxide

[05037881174174]

Ethylene Oxide

[05037881174174]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-12
• Device Publish Date: 2025-09-04

On-Brand Devices [Thoraflex™ Hybrid]

• 05037881027081: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881027074: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881027067: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881027050: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881027043: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881027036: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881027029: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881027012: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881027005: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026992: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026985: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026978: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026961: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026954: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026947: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026930: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026923: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026916: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026909: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026893: Thoraflex Hybrid Ante-Flo Hybrid Stent Device
• 05037881026879: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026862: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026855: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026848: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026831: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026824: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026817: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026800: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026794: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026787: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026770: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026763: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026756: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026749: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026732: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026725: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026718: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026701: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026695: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881026626: Thoraflex Hybrid Plexus 4 Hybrid Stent Device
• 05037881174600: Thoraflex Hybrid Ante-Flo
• 05037881174587: Thoraflex Hybrid Ante-Flo
• 05037881174556: Thoraflex Hybrid Ante-Flo
• 05037881174532: Thoraflex Hybrid Ante-Flo
• 05037881174518: Thoraflex Hybrid Ante-Flo
• 05037881174488: Thoraflex Hybrid Ante-Flo
• 05037881174471: Thoraflex Hybrid Ante-Flo
• 05037881174426: Thoraflex Hybrid Ante-Flo
• 05037881174396: Thoraflex Hybrid Ante-Flo
• 05037881174341: Thoraflex Hybrid Ante-Flo