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 - 00389701007502 Catalog Number : RSS902

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007519 Catalog Number : RSS002

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007526 Catalog Number : RSS102

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007533 Catalog Number : RSB601

Device Description : PINNACLE R/O II Introducer Sheath with Radiopaque Marker

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007540 Catalog Number : RSB701

Device Description : PINNACLE R/O II Introducer Sheath with Radiopaque Marker

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007557 Catalog Number : RSB801

Device Description : PINNACLE R/O II Introducer Sheath with Radiopaque Marker

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007564 Catalog Number : RSB602

Device Description : PINNACLE R/O II Introducer Sheath with Radiopaque Marker

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007571 Catalog Number : RSB702

Device Description : PINNACLE R/O II Introducer Sheath with Radiopaque Marker

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007588 Catalog Number : RSB802

Device Description : PINNACLE R/O II Introducer Sheath with Radiopaque Marker

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007595 Catalog Number : RSB603

Device Description : PINNACLE R/O II Introducer Sheath with Radiopaque Marker

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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