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 - 00389701007403 Catalog Number : RSS605

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007410 Catalog Number : RSS705

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007427 Catalog Number : RSS805

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007434 Catalog Number : RSS905

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007441 Catalog Number : RSS005

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007458 Catalog Number : RSS105

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007465 Catalog Number : RSS502

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007472 Catalog Number : RSS602

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007489 Catalog Number : RSS702

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007496 Catalog Number : RSS802

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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