COOK IRELAND LTD

Address:O HALLORAN ROAD,LIMERICK,IE

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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

CATHETER, BILIARY, DIAGNOSTIC (FGE) (10)

Premarket Exempt

Clear

Soehendra Tannenbaum - 00827002214378 Catalog Number : TTSO-10-6

Device Description : ST-2 Soehendra Tannenbaum, Biliary Stents

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Soehendra Tannenbaum - 00827002214385 Catalog Number : TTSO-10-7

Device Description : ST-2 Soehendra Tannenbaum, Biliary Stents

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Zimmon - 00827002214392 Catalog Number : ZEBD-11.5-5

Device Description : Zimmon, Biliary Stent Set

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Soehendra Tannenbaum - 00827002214408 Catalog Number : TTSO-10-8

Device Description : ST-2 Soehendra Tannenbaum, Biliary Stents

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Soehendra Tannenbaum - 00827002214415 Catalog Number : TTSO-10-9

Device Description : ST-2 Soehendra Tannenbaum, Biliary Stents

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Zimmon - 00827002214422 Catalog Number : ZEBD-11.5-7

Device Description : Zimmon, Biliary Stent Set

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Cook - 00827002214439 Catalog Number :

Device Description : Pushing Catheter

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Zimmon - 00827002214460 Catalog Number : ZEBD-11.5-9

Device Description : Zimmon, Biliary Stent Set

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Huibregtse - 00827002214484 Catalog Number :

Device Description : Huibregtse, Guiding Catheter

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Cotton-Huibregtse - 00827002214545 Catalog Number : CHBS-10-3

Device Description : Cotton-Huibregtse, Biliary Stent Set

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

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