Thoraflex™ Hybrid THA3034X150A

GUDID 05037881027043

Thoraflex Hybrid Ante-Flo Hybrid Stent Device

VASCUTEK LTD

Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Fluoroscopic x-ray system video image recording unit Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft Synthetic vascular graft
Primary Device ID05037881027043
NIH Device Record Key363fc898-ae72-4f42-a6c1-d57790c7dded
Commercial Distribution StatusIn Commercial Distribution
Brand NameThoraflex™ Hybrid
Version Model NumberTHA3034X150A
Catalog NumberTHA3034X150A
Company DUNS229053087
Company NameVASCUTEK LTD
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length242150 Millimeter
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Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
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Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
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Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter
Length242150 Millimeter
Device Size Text, specify0
Device Size Text, specify0
Lumen/Inner Diameter30 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place out of direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS105037881027043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QSKHybrid stent graft, thoracic aortic lesion treatment

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-08
Device Publish Date2022-05-31

On-Brand Devices [Thoraflex™ Hybrid]

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

Trademark Results [Thoraflex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THORAFLEX
THORAFLEX
97673743 not registered Live/Pending
Vascutek Limited
2022-11-11
THORAFLEX
THORAFLEX
79081392 4235676 Live/Registered
Vascutek Limited
2010-02-19

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