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 - 00389701007304 Catalog Number : RSS101

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007311 Catalog Number : RSS403

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007328 Catalog Number : RSS503

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007335 Catalog Number : RSS603

Device Description : PINNACLE Introducer Sheath

Device Class : 2

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007342 Catalog Number : RSS703

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007359 Catalog Number : RSS803

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007366 Catalog Number : RSS903

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007373 Catalog Number : RSS003

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007380 Catalog Number : RSS103

Device Description : PINNACLE Introducer Sheath

Device Class :

Duns Number: 131489882

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PINNACLE - 00389701007397 Catalog Number : RSS505

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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