FDA.reportPublic FDA data

COOK

Primary DI
10827002474960
Brand
COOK
Company
William Cook Europe ApS
Model
G47496
Catalog number
ZDES-46-185-US
Device description
Zenith, Dissection Endovascular Stent, With the Z-Trak Plus Introduction System
Published
2019-03-27
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
MIHSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIHSystem, Endovascular Graft, Aortic Aneurysm TreatmentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180001000Zenith Dissection Endovascular SystemWilliam Cook Europe Aps2018-12-31MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002474960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700247496010827002474960

GMDN Terms#

Term, Definition table
TermDefinition
Bare-metal aortic stentA sterile non-bioabsorbable tubular device intended to be implanted in the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is made of metal (e.g., platinum/iridium wire with gold braze) and may be inserted with a balloon catheter which when inflated causes the device to expand, or the device may self-expand after being delivered to the site of implantation. The device is typically a mesh structure in tubular form; it is available in a variety of lengths and diameters. Disposable devices associated with implantation may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
305302119
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002599109Zenith AlphaG59910ZTA2-P-46-179-W2024-12-03
00827002599123Zenith AlphaG59912ZTA2-P-46-233-W2024-12-03
00827002599154Zenith AlphaG59915ZTA2-P-40-117-W2024-12-03
00827002599185Zenith AlphaG59918ZTA2-P-40-142-W2024-12-03
00827002599215Zenith AlphaG59921ZTA2-P-40-167-W2024-12-03
00827002599239Zenith AlphaG59923ZTA2-P-40-217-W2024-12-03
00827002599260Zenith AlphaG59926ZTA2-P-42-121-W2024-12-03
00827002599321Zenith AlphaG59932ZTA2-P-42-173-W2024-12-03
00827002599352Zenith AlphaG59935ZTA2-P-42-225-W2024-12-03
00827002599383Zenith AlphaG59938ZTA2-P-44-125-W2024-12-03
00827002599413Zenith AlphaG59941ZTA2-P-44-152-W2024-12-03
00827002599444Zenith AlphaG59944ZTA2-P-44-179-W2024-12-03
00827002599475Zenith AlphaG59947ZTA2-P-44-233-W2024-12-03
00827002599505Zenith AlphaG59950ZTA2-P-46-125-W2024-12-03
00827002599567Zenith AlphaG59956ZTA2-P-24-105-W2024-12-03
00827002599581Zenith AlphaG59958ZTA2-P-24-127-W2024-12-03
00827002599604Zenith AlphaG59960ZTA2-P-26-105-W2024-12-03
00827002599659Zenith AlphaG59965ZTA2-P-28-109-W2024-12-03
00827002599697Zenith AlphaG59969ZTA2-P-28-132-W2024-12-03
00827002599727Zenith AlphaG59972ZTA2-P-28-155-W2024-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00733132666980GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132666997GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667000GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667017GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00733132667024GORE® TAG® Thoracic Branch EndoprosthesisW. L. Gore & Associates, Inc.MIH2026-05-26
00827002603400COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603417COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603424COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603431COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603448COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603455COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603462COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00827002603479COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603407COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603414COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603421COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603438COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603445COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603452COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603469COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
10827002603476COOKWILLIAM A. COOK AUSTRALIA PTY. LTD.MIH2025-06-24
00733132661664GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661671GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661688GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00733132661695GORE TAG Conformable Thoracic Stent GraftW. L. Gore & Associates, Inc.MIH2025-03-18
00827002601598Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601659Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601710Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601741Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18
00827002601772Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18