CELONOVA BIOSCIENCES, INC.

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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

Stent, Coronary (MAF) (6) Device, Vascular, For Promoting Embolization (KRD) (4)

Premarket Exempt

Clear

ONCOZENE Microspheres - 00879397000265 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : KRD

Prescription Use : No

Device Count : 1

ONCOZENE Microspheres - 00879397000272 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : KRD

Prescription Use : No

Device Count : 1

ONCOZENE Microspheres - 00879397000289 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : KRD

Prescription Use : No

Device Count : 1

ONCOZENE Microspheres - 00879397000296 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : KRD

Prescription Use : No

Device Count : 1

Cobra PzF - 00879397000654 Catalog Number : 170-03-25008

Device Description : NanoCoated Coronary Stent System

Device Class : 3

Duns Number: 168593429

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

Cobra PzF - 00879397000661 Catalog Number : 170-03-25012

Device Description : NanoCoated Coronary Stent System

Device Class : 3

Duns Number: 168593429

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

Cobra PzF - 00879397000678 Catalog Number : 170-03-25015

Device Description : NanoCoated Coronary Stent System

Device Class : 3

Duns Number: 168593429

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

Cobra PzF - 00879397000685 Catalog Number : 170-03-25018

Device Description : NanoCoated Coronary Stent System

Device Class : 3

Duns Number: 168593429

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

Cobra PzF - 00879397000692 Catalog Number : 170-03-25024

Device Description : NanoCoated Coronary Stent System

Device Class : 3

Duns Number: 168593429

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

Cobra PzF - 00879397000708 Catalog Number : 170-03-25030

Device Description : NanoCoated Coronary Stent System

Device Class : 3

Duns Number: 168593429

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

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