FDA.reportPublic FDA data

COOK

Primary DI
00827002603448
Brand
COOK
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G60344
Catalog number
ZBIS-12-45-41-US
Device description
Zenith Iliac Branch
Published
2025-06-24
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
P020018064

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020018064ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMCook, Inc.2003-05-23MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002603445PackageGS11In Commercial Distribution
00827002603448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700260344510827002603445
00827002603448008270026034488270026034480827002603448

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graft, non-medicatedAn implantable artificial substitute for a blood vessel intended to replace, bypass or shunt a portion of peripheral vasculature (excludes coronary and cerebral arteries) due to a disease, injury, or for haemodialysis access. It is made of synthetic polymer materials [e.g., woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics]; it does not contain any pharmaceuticals and does not incorporate a metallic mesh (i.e., it is not a stent-graft).

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
758568000
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
00827002384354CookG38435K-OSN-1735-A-90-US2016-09-24
00827002384361CookG38436K-OSN-1735-B-60-US2016-09-24
00827002384378CookG38437K-OSN-1735-B-90-US2016-09-24
00827002483637CookG48363K-OSN-1730-B-90-US2016-09-24
00827002552531CookG55253K-OSN-1733-R-B-902016-09-24
00827002554764CookG55476K-UCI-1735-R-CTU2016-09-24
00827002554771CookG55477K-OSN-1735-R-B-902016-09-24
00827002557857CookG55785K-OPSD-1630-A-L-US2016-09-24
00827002557864CookG55786K-OPSD-1630-A-S-US2016-09-24
00827002557871CookG55787K-OPSD-1635-A-L-US2016-09-24
00827002557888CookG55788K-OPSD-1635-A-S-US2016-09-24
00827002557895CookG55789K-OPSD-1633-A-S-US2016-09-24
00827002557901CookG55790K-OPSD-1630-B-L-US2016-09-24
00827002557918CookG55791K-OPSD-1630-B-S-US2016-09-24
00827002557925CookG55792K-OPSD-1635-B-S-US2016-09-24
00827002557963CookG55796K-OPSD-1735-A-L-US2016-09-24
00827002557970CookG55797K-OPSD-1735-A-S-US2016-09-24
00827002557987CookG55798K-OPSD-1735-B-S-US2016-09-24
00827002341753CookG34175K-DOPU-1735-T-A-602016-09-24
00827002341869CookG34186K-DOPU-1735-T-A-902016-09-24

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
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
00827002601802Zenith AlphaWilliam Cook Europe ApSMIH2024-12-18