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

Agents,Embolic,For Treatment Of Uterine Fibroids (NAJ) (6) Device, Vascular, For Promoting Embolization (KRD) (6) Stent, Coronary (MAF) (4)

Premarket Exempt

Clear

Cobra PzF - 00879397000913 Catalog Number : 170-03-40015

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 - 00879397000920 Catalog Number : 170-03-40018

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 - 00879397000937 Catalog Number : 170-03-40024

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 - 00879397000944 Catalog Number : 170-03-40030

Device Description : NanoCoated Coronary Stent System

Device Class : 3

Duns Number: 168593429

Premarket Exempt : No

Product Code : MAF

Prescription Use : Yes

Device Count : 1

Embozene Microspheres (Color-Advanced) - 00879397001118 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : NAJ, KRD

Prescription Use : No

Device Count : 1

Embozene Microspheres (Color-Advanced) - 00879397001125 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : NAJ, KRD

Prescription Use : No

Device Count : 1

Embozene Microspheres (Color-Advanced) - 00879397002115 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : NAJ, KRD

Prescription Use : No

Device Count : 1

Embozene Microspheres (Color-Advanced) - 00879397002122 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : NAJ, KRD

Prescription Use : No

Device Count : 1

Embozene Microspheres (Opaque) - 00879397003228 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : NAJ, KRD

Prescription Use : No

Device Count : 1

Embozene Microspheres (Opaque) - 00879397003235 Catalog Number :

Device Description : Microspheres for Embolization

Device Class : 2

Duns Number: 168593429

Premarket Exempt : No

Product Code : NAJ, KRD

Prescription Use : No

Device Count : 1

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