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 - 00389701007601 Catalog Number : RSB703

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 - 00389701007618 Catalog Number : RSB803

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 - 00389701007625 Catalog Number : RSS404

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007632 Catalog Number : RSS504

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007649 Catalog Number : RSS604

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007656 Catalog Number : RSS704

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007663 Catalog Number : RSS804

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007670 Catalog Number : RSS904

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007687 Catalog Number : RSS004

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007694 Catalog Number : RSS104

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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