Oscor Inc.

Address:3816 Desoto Blvd,PALM HARBOR,FL,34683,US

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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

Electrode, Pacemaker, Temporary (LDF) (5) INTRODUCER, CATHETER (DYB) (5)

Premarket Exempt

Clear

Introducer Kit for Impella® - 00813502010558 Catalog Number : 0052-3021

Device Description : Hemostatic Peel Away Introducer System with Infusion Sideport, 23F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Introducer Kit for Impella® - 00813502010664 Catalog Number : 0052-3025

Device Description : Hemostatic Peel Away Introducer System with Infusion Sideport, 13 cm and 25 cm

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Introducer Kit for Impella® - 00813502011517 Catalog Number : 0052-3001

Device Description : Hemostatic Peel Away Introducer System with Infusion Sideport, 23F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Introducer Kit for Impella® - 00813502011562 Catalog Number : 0052-3000

Device Description : Hemostatic Peel Away Introducer System with Infusion Sideport, 14F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Introducer Kit for Impella® - 00813502011609 Catalog Number : 0052-3006

Device Description : Hemostatic Peel Away Introducer System with Infusion Sideport, 23F

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Temporary Myocardial Heartwire - 00836559001782 Catalog Number :

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

Temporary Myocardial Heartwire - 00836559001805 Catalog Number :

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

Temporary Myocardial Heartwire - 00836559001829 Catalog Number :

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

Temporary Myocardial Heartwire - 00836559001850 Catalog Number :

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

Temporary Myocardial Heartwire - 00836559001874 Catalog Number :

Device Class : 2

Duns Number: 101835833

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

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