Thoraflex™ Hybrid

Primary DI
05037881031941
Brand
Thoraflex™ Hybrid
Company
VASCUTEK LTD
Model
THA2830X100B
Catalog number
THA2830X100B
Device description
Thoraflex Hybrid Ante-Flo
Published
2025-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSKHybrid stent graft, thoracic aortic lesion treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSKHybrid Stent Graft, Thoracic Aortic Lesion TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210006000
P210006001
P210006002
P210006003
P210006004
P210006005
P210006006
P210006007
P210006009
P210006010
P210006011
P210006012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210006000Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006001Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006002Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006003Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006004Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006005Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006006Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006007Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006009Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006010Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006011Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK
P210006012Thoraflex™ HybridVascutek, Ltd.2022-04-19QSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05037881031941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05037881031941050378810319415037881031941

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftAn implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Stent Diameter30Millimeter
Stent Length100Millimeter

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+44441418125555tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
229053087
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05037881184883Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184890Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184906Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184913Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184920Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184937Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881026626Thoraflex™ HybridTHP2224X100ATHP2224X100A2022-05-31
05037881026695Thoraflex™ HybridTHP2426X100ATHP2426X100A2022-05-31
05037881026725Thoraflex™ HybridTHP3032X100ATHP3032X100A2022-05-31
05037881026756Thoraflex™ HybridTHP3038X100ATHP3038X100A2022-05-31
05037881026800Thoraflex™ HybridTHP2628X150ATHP2628X150A2022-05-31
05037881026848Thoraflex™ HybridTHP3036X150ATHP3036X150A2022-05-31
05037881026923Thoraflex™ HybridTHA2830X100ATHA2830X100A2022-05-31
05037881026947Thoraflex™ HybridTHA3034X100ATHA3034X100A2022-05-31
05037881027029Thoraflex™ HybridTHA2830X150ATHA2830X150A2022-05-31
05037881027067Thoraflex™ HybridTHA3038X150ATHA3038X150A2022-05-31
05037881027074Thoraflex™ HybridTHA3040X150ATHA3040X150A2022-05-31
05037881031712Thoraflex™ HybridTHP2224X100BTHP2224X100B2025-09-04
05037881031729Thoraflex™ HybridTHP2426X100BTHP2426X100B2025-09-04
05037881031736Thoraflex™ HybridTHP2628X100BTHP2628X100B2025-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05037881031712Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031729Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031736Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031743Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031750Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031767Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031774Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031781Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031798Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031804Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031811Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031828Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031835Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031842Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031859Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031866Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031873Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031880Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031897Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031903Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031910Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031927Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031934Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031958Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031965Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031972Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031989Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881031996Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881032009Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04
05037881032016Thoraflex™ HybridVASCUTEK LTDQSK2025-09-04