William Cook Europe ApS

Address:SANDET 6,BJAEVERSKOV Sjalland,DK

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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

WIRE, GUIDE, CATHETER (DQX) (6) Device, Vascular, for Promoting Embolization (KRD) (2) Tube, tracheal (w/wo connector) (BTR) (2)

Premarket Exempt

Clear

Flipper - 00827002129122 Catalog Number : FDW-35-80

Device Description : Flipper, Delivery System

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Flipper - 00827002129139 Catalog Number : FDW-35-110

Device Description : Flipper, Delivery System

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : KRD

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002204836 Catalog Number : TSCMG-35-90-5-3-LES1

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002204904 Catalog Number : TSCMG-35-90-3-3-LES1

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

COOK - 00827002236455 Catalog Number : C-CAE-14.0-70-FI

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

COOK - 00827002236462 Catalog Number : C-CAE-14.0-70-FII

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : BTR

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002288850 Catalog Number : TSMG-35-90-3-LES1

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002288881 Catalog Number : TSMG-35-90-7-LES1

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002314535 Catalog Number : TSMG-35-260-LES

Device Description : Lunderquist, Extra Stiff Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

Lunderquist - 00827002452084 Catalog Number : TSCMG-35-260-LESDC

Device Description : Lunderquist, Extra Stiff DC Wire Guide

Device Class : 2

Duns Number: 305302119

Premarket Exempt : No

Product Code : DQX

Prescription Use : Yes

Device Count : 1

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