BRACCO DIAGNOSTICS 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

Media,Coupling,Ultrasound (MUI) (4) Catheter, Retention, Barium Enema With Bag (FGD) (3) Aspiration Tray (OJT) (1) Insufflator, Automatic Carbon-Dioxide For Endoscope (FCX) (1) Nerve Block Tray (OGJ) (1)

Premarket Exempt

No Yes

Clear

E-Z-GEL UltraSound Gel - 10815112020535 Catalog Number : 601001

Device Description : EZ Gel 8oz

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

E-Z-SCAN Low Viscosity UltraSound Gel - 10815112020542 Catalog Number : 601002

Device Description : EZ Scan 8oz Tube

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

E-Z-SCAN Low Viscosity UltraSound Gel - 10815112020559 Catalog Number : 601003

Device Description : EZ Scan Pack

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

E-Z-GEL UltraSound Gel - 10815112020566 Catalog Number : 601004

Device Description : EZ Gel 5L

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : MUI

Prescription Use : No

Device Count : 1

Enema Kit: Empty Enema Bag Delivery System - 10815112020634 Catalog Number : 900303

Device Description : Empty Snap Cap Bag

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

FLEXI-STOME Cone Colostomy Tip - 10815112020641 Catalog Number : 901306

Device Description : Cone Colostomy Tip

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

Protocol Touch Colon Insufflator - 10815112020672 Catalog Number : 390308

Device Description : Protocol Touch Insufflator

Device Class :

Duns Number: 849234661

Premarket Exempt : No

Product Code : FCX

Prescription Use : Yes

Device Count : 1

PercuSet Local Anesthesia Tray - 10815112020764 Catalog Number : 600601

Device Description : PercuSet Local Anesthesia Tray

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : OGJ

Prescription Use : Yes

Device Count : 1

PercuSet Basic Biopsy Tray - 10815112020771 Catalog Number : 600602

Device Description : Basic Biopsy Tray w/o Biopsy Needle

Device Class : 1

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : OJT

Prescription Use : Yes

Device Count : 1

Enema Kit: Empty Enema Bag Delivery System - 10815112020818 Catalog Number : 900302

Device Description : Empty Snap Cap Bag

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

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