Zenith TX2 Pro-Form ESBE-36-77-T-PF-US

GUDID 10827002534664

Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension

William Cook Europe ApS

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 ID10827002534664
NIH Device Record Key0b79018c-78da-402c-9283-8e602466305b
Commercial Distribution Discontinuation2019-09-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZenith TX2 Pro-Form
Version Model NumberG53466
Catalog NumberESBE-36-77-T-PF-US
Company DUNS305302119
Company NameWilliam Cook Europe ApS
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dark, dry, cool place.

Device Identifiers

Device Issuing AgencyDevice ID
GS110827002534664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-26
Device Publish Date2014-09-24

On-Brand Devices [Zenith TX2 Pro-Form]

10827002534879Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534862Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534855Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534848Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534831Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534824Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534817Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534800Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534794Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534787Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534770Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534763Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534749Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534732Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534725Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534718Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Component
10827002534695Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension
10827002534688Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension
10827002534671Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension
10827002534664Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension
10827002534657Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension
10827002534640Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension
10827002534633Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension
10827002534626Zenith TX2, TAA Endovascular Graft with Pro-Form, Distal Extension
10827002534619Zenith TX2,TAA Endovascular Graft with Pro-Form, Proximal Extension
10827002534602Zenith TX2,TAA Endovascular Graft with Pro-Form, Proximal Extension
10827002534596Zenith TX2,TAA Endovascular Graft with Pro-Form, Proximal Extension
10827002534589Zenith TX2,TAA Endovascular Graft with Pro-Form, Proximal Extension
10827002534572Zenith TX2,TAA Endovascular Graft with Pro-Form, Proximal Extension
10827002534565Zenith TX2,TAA Endovascular Graft with Pro-Form, Proximal Extension
10827002534558Zenith TX2,TAA Endovascular Graft with Pro-Form, Proximal Extension
10827002534541Zenith TX2,TAA Endovascular Graft with Pro-Form, Proximal Extension
10827002534534Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534527Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534510Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534503Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534497Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534480Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534473Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534466Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534459Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534442Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534435Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534428Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component
10827002534411Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Component
10827002534404Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Component
10827002534398Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Component
10827002534381Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Component
10827002534374Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Component
10827002534367Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Component
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.