FDA.reportPublic FDA data

Zenith Flex

Primary DI
10827002484655
Brand
Zenith Flex
Company
COOK INCORPORATED
Model
G48465
Catalog number
TFLE-18-56-ZT
Device description
Zenith Flex, AAA Endovascular Graft Iliac Leg
Published
2014-09-24
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002484655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700248465510827002484655

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic vascular graftAn implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.

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
042823948
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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00827002599819Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599840Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599871Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599901Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599932Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599963Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002599994Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600027Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600058Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600089Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600119Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600140Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600171Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600201Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600232Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600263Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600294Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600324Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600355Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600393Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600409Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600430Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600461Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600492Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600522Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600553Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600584Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600614Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600645Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04
00827002600676Zenith AlphaWilliam Cook Europe ApSMIH2024-12-04