SEQUENT MEDICAL, INC.

Address:35 Enterprise,Aliso Viejo,CA,92656,US

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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

Intrasaccular Flow Disruption Device (OPR) (10)

Premarket Exempt

Clear

WEB Aneurysm Embolization System - 00854111006167 Catalog Number : FGA25070-060

Device Description : WEB 21 SL 7x6

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Detachment Controller - 00856956005282 Catalog Number : FGA00175

Device Description : WEB Detachment Controller

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Aneurysm Embolization System - 00856956005541 Catalog Number : FGA15080-001

Device Description : WEB 27 SLS 8

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Aneurysm Embolization System - 00856956005558 Catalog Number : FGA15090-001

Device Description : WEB 27 SLS 9

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Aneurysm Embolization System - 00856956005565 Catalog Number : FGA15100-001

Device Description : WEB 27 SLS 10

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Aneurysm Embolization System - 00856956005572 Catalog Number : FGA15110-001

Device Description : WEB 27 SLS 11

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Aneurysm Embolization System - 00856956005817 Catalog Number : FGA15080-040

Device Description : WEB 27 SL 8x4

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Aneurysm Embolization System - 00856956005824 Catalog Number : FGA15080-050

Device Description : WEB 27 SL 8x5

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Aneurysm Embolization System - 00856956005831 Catalog Number : FGA15080-060

Device Description : WEB 27 SL 8x6

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

WEB Aneurysm Embolization System - 00856956005848 Catalog Number : FGA15080-070

Device Description : WEB 27 SL 8x7

Device Class : 3

Duns Number: 796807340

Premarket Exempt : No

Product Code : OPR

Prescription Use : Yes

Device Count : 1

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