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

K-Pack II - 05413206042319 Catalog Number : KN-2913RBKT

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 Surshield™ - 05413206050260 Catalog Number : KN-S2516RB

Device Description : K-Pack Surshield™ Needle

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

K-Pack Surshield™ - 05413206050277 Catalog Number : KN-S2713RB

Device Description : K-Pack Surshield™ Needle

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

K-Pack II - 05413206051038 Catalog Number : KN-2713RBKT

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 - 05413206051045 Catalog Number : KN-3013RBKT

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 - 05413206052677 Catalog Number : KN-2616RB

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 - 05413206054558 Catalog Number : KN-2719RBT

Device Description : K-Pack II Needle

Device Class : 2

Duns Number: 370193559

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

SURFLO® - 05413206054886 Catalog Number : SV-S23BL35

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® - 05413206054909 Catalog Number : SV-S25BL35

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® - 05413206054923 Catalog Number : SV-S23FL35

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

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