WILLIAM A. COOK AUSTRALIA PTY. LTD.

Address:95 BRANDL ST,EIGHT MILE PLAINS Queensland,AU

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT (MIH) (9)

Premarket Exempt

Clear

Zenith - 10827002325842 Catalog Number : ZFEN-D-12-62-106-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

Zenith - 10827002325859 Catalog Number : ZFEN-D-16-62-106-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

Zenith - 10827002325866 Catalog Number : ZFEN-D-20-62-106-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

Zenith - 10827002325873 Catalog Number : ZFEN-D-24-62-106-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

Zenith - 10827002325880 Catalog Number : ZFEN-D-12-62-121-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

Zenith - 10827002325897 Catalog Number : ZFEN-D-16-62-121-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

Zenith - 10827002325903 Catalog Number : ZFEN-D-20-62-121-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

Zenith - 10827002325910 Catalog Number : ZFEN-D-24-62-121-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

Zenith - 10827002325927 Catalog Number : ZFEN-D-16-62-76-C

Device Description : Zenith Fenestrated, AAA Endovascular Graft, Distal Body

Device Class : 3

Duns Number: 758568000

Premarket Exempt : No

Product Code : MIH

Prescription Use : Yes

Device Count : 1

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