FDA.reportPublic FDA data

Zenith

Primary DI
10827002325026
Brand
Zenith
Company
WILLIAM A. COOK AUSTRALIA PTY. LTD.
Model
G32502
Catalog number
ZFEN-P-1-24-76-R
Device description
Zenith Fenestrated, AAA Endovascular Graft, Proximal Body
Published
2014-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
P020018040
P020018043
P020018044
P020018045
P020018046
P020018048
P020018050

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P020018040ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMCook, Inc.2003-05-23MIH
P020018043ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMCook, Inc.2003-05-23MIH
P020018044ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMCook, Inc.2003-05-23MIH
P020018045ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMCook, Inc.2003-05-23MIH
P020018046ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMCook, Inc.2003-05-23MIH
P020018048ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMCook, Inc.2003-05-23MIH
P020018050ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEMCook, Inc.2003-05-23MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002325026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700232502610827002325026

GMDN Terms#

Term, Definition table
TermDefinition
Aortoiliac endovascular stent-graftA non-bioabsorbable tubular device typically implanted at the junction of the abdominal aorta and the common iliac arteries to reduce pressure on an abdominal aortic aneurysm (AAA) [includes aortoiliac aneurysm]; it does not contain anticoagulants or pharmaceuticals. It is percutaneously inserted via the femoral artery to the site of implantation where it self-expands. It is made of a metallic mesh structure with a polymer tube (endovascular graft) and is typically available as a: 1) single tube for insertion into the aorta and/or one iliac artery; or 2) two-part bifurcation design (e.g., Y-shaped tube) for insertion through both iliac arteries.

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002603400COOKG60340ZBIS-10-45-41-US2025-06-24
00827002603417COOKG60341ZBIS-10-45-58-US2025-06-24
00827002603424COOKG60342ZBIS-10-61-41-US2025-06-24
00827002603431COOKG60343ZBIS-10-61-58-US2025-06-24
00827002603448COOKG60344ZBIS-12-45-41-US2025-06-24
00827002603455COOKG60345ZBIS-12-61-41-US2025-06-24
00827002603462COOKG60346ZBIS-12-45-58-US2025-06-24
00827002603479COOKG60347ZBIS-12-61-58-US2025-06-24
10827002325033ZenithG32503ZFEN-P-1-26-76-R2014-09-24
10827002325071ZenithG32507ZFEN-P-1-24-91-R2014-09-24
10827002325125ZenithG32512ZFEN-P-1-24-106-R2014-09-24
10827002325132ZenithG32513ZFEN-P-1-26-106-R2014-09-24
10827002325170ZenithG32517ZFEN-P-1-24-121-R2014-09-24
10827002325187ZenithG32518ZFEN-P-1-26-121-R2014-09-24
10827002325309ZenithG32530ZFEN-P-2-24-94-R2014-09-24
10827002325316ZenithG32531ZFEN-P-2-26-94-R2014-09-24
10827002325323ZenithG32532ZFEN-P-2-28-94-R2014-09-24
10827002325330ZenithG32533ZFEN-P-2-30-94-R2014-09-24
10827002325347ZenithG32534ZFEN-P-2-32-94-R2014-09-24
10827002325354ZenithG32535ZFEN-P-2-24-109-R2014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00843576150416RelayPro NBS Thoracic Stent-Graft SystemBolton Medical Inc.MIH2023-04-24
00843576150546RelayPro NBS Thoracic Stent-Graft SystemBolton Medical Inc.MIH2023-04-24
00843576150676RelayPro NBS Thoracic Stent-Graft SystemBolton Medical Inc.MIH2023-04-24
00843576150805RelayPro NBS Thoracic Stent-Graft SystemBolton Medical Inc.MIH2023-04-24
00843576150874RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-23
00843576150188RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150195RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150201RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150218RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150225RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150232RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150249RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150256RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150263RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150270RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150287RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150294RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150300RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150317RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150324RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150331RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22
00843576150348RelayPro Thoracic Stent-Graft SystemBolton Medical Inc.MIH2021-09-22