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

Geenen Sof-Flex - 10827002496665 Catalog Number : GPSO-SF-5-9

Device Description : Geenen Sof-Flex Pancreatic Stent

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Geenen Sof-Flex - 10827002496672 Catalog Number : GPSO-SF-5-12

Device Description : Geenen Sof-Flex Pancreatic Stent

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Geenen Sof-Flex - 10827002496689 Catalog Number : GPSOS-SF-5-3

Device Description : Geenen Sof-Flex Pancreatic Stent

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Geenen Sof-Flex - 10827002496696 Catalog Number : GPSOS-SF-5-5

Device Description : Geenen Sof-Flex Pancreatic Stent

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Geenen Sof-Flex - 10827002496702 Catalog Number : GPSOS-SF-5-7

Device Description : Geenen Sof-Flex Pancreatic Stent

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Geenen Sof-Flex - 10827002496719 Catalog Number : GPSOS-SF-5-9

Device Description : Geenen Sof-Flex Pancreatic Stent

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Geenen Sof-Flex - 10827002496726 Catalog Number : GPSOS-SF-5-12

Device Description : Geenen Sof-Flex Pancreatic Stent

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Zilver 635 - 10827002506166 Catalog Number : ZILBS-635-6-4

Device Description : Zilver 635 Biliary Stent, Expandable Metal Biliary Stent System

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Zilver 635 - 10827002506173 Catalog Number : ZILBS-635-8-4

Device Description : Zilver 635 Biliary Stent, Expandable Metal Biliary Stent System

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Zilver 635 - 10827002506180 Catalog Number : ZILBS-635-10-4

Device Description : Zilver 635 Biliary Stent, Expandable Metal Biliary Stent System

Device Class : 2

Duns Number: 988559035

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

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