Thoraflex™ Hybrid

Primary DI
05037881026985
Brand
Thoraflex™ Hybrid
Company
VASCUTEK LTD
Model
THA3240X100A
Catalog number
THA3240X100A
Device description
Thoraflex Hybrid Ante-Flo Hybrid Stent Device
Published
2022-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05037881026985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05037881026985050378810269855037881026985

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopic x-ray system video image recording unitAn assembly of devices that are part of a fluoroscopic x-ray system and specifically designed to display x-ray images in real-time. It is often referred to as an x-ray imaging chain. It includes a video camera [charge-coupled device (CCD) or tube based], a video signal generator, and cabling used to convert the analogue image taken from the output raster of the x-ray image intensifier and to display it on one or more image display monitors [visual display unit (VDU)] for immediate viewing.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length242100Millimeter
Lumen/Inner Diameter32Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place out of direct sunlight
Special Storage Condition, Specify00Store in a cool, dry place

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
229053087
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
05037881031941Thoraflex™ 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