Terumo Europe NV

Address:INTERLEUVENLAAN 40,LEUVEN Vlaams Brabant,BE

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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

Needle, Hypodermic, Single Lumen (FMI) (7) Set, Administration, Intravascular (FPA) (3)

Premarket Exempt

Clear

SURFLO® - 05413206054947 Catalog Number : SV-S25FL35

Device Description : SURFLO® WINGED INFUSION SET WITH FILTER AND NEEDLE PROTECTION

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

SURFLO® - 05413206055906 Catalog Number : SV-S23WL35

Device Description : SURFLO® WINGED INFUSION SET WITH NEEDLE PROTECTION

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

SURFLO® - 05413206055913 Catalog Number : SV-S25WL35

Device Description : SURFLO® WINGED INFUSION SET WITH NEEDLE PROTECTION

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FPA

Prescription Use : Yes

Device Count : 1

K-Pack II - 05413206203543 Catalog Number : KN-2719RB

Device Description : K-Pack II Needle

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

K-Pack II - 05413206203550 Catalog Number : KN-2038RB

Device Description : K-Pack II Needle

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

K-Pack II - 05413206203642 Catalog Number : KN-2150RB

Device Description : K-Pack II Needle

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

K-Pack II - 05413206211050 Catalog Number : KN-2908RBKT

Device Description : K-Pack II Needle

Device Class :

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

K-Pack II - 05413206211135 Catalog Number : KN-2232RBB

Device Description : K-Pack II Needle

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

K-Pack II - 05413206211418 Catalog Number : KN-2719RBTS

Device Description : K-Pack II Needle

Device Class :

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

K-Pack II - 05413206211951 Catalog Number : KN-2713RBKT50

Device Description : K-Pack II Needle

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

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