TERUMO MEDICAL CORPORATION

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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

INTRODUCER, CATHETER (DYB) (10)

Premarket Exempt

Clear

PINNACLE - 00389701007700 Catalog Number : RSS506

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007717 Catalog Number : RSS606

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007724 Catalog Number : RSS706

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007731 Catalog Number : RSS806

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007748 Catalog Number : RSS906

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007755 Catalog Number : RSS006

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007762 Catalog Number : RSS106

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701007786 Catalog Number : RSP01

Device Description : DESTINATION Peripheral Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701007793 Catalog Number : RSP02

Device Description : DESTINATION Peripheral Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

DESTINATION - 00389701007809 Catalog Number : RSP03

Device Description : DESTINATION Peripheral Guiding Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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