FDA.reportPublic FDA data

Zenith Alpha

Primary DI
00827002599321
Brand
Zenith Alpha
Company
William Cook Europe ApS
Model
G59932
Catalog number
ZTA2-P-42-173-W
Device description
Zenith Alpha 2, Thoracic Endovascular Graft Proximal Component
Published
2024-12-03
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
P140016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P140016000ZENITH ALPHA THORACIC ENDOVASCULAR GRAFTCook Medical Incorporated2015-09-15MIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002599328PackageGS11In Commercial Distribution
00827002599321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700259932810827002599328
00827002599321008270025993218270025993210827002599321

GMDN Terms#

Term, Definition table
TermDefinition
Descending thoracic aorta endovascular stent-graftA non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.

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
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
00827002314535LunderquistG31453TSMG-35-260-LES2016-09-24
00827002483033COOKG48303C-CAE-14.0-70-FIC2019-01-18
00827002236455COOKG23645C-CAE-14.0-70-FI2019-01-18
00827002236462COOKG23646C-CAE-14.0-70-FII2019-01-18
00827002535176COOKG53517C-CAE-14.0-70-FIC-SPOPS2019-01-18
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
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

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