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

Catheter, Retention, Barium Enema With Bag (FGD) (10)

Premarket Exempt

No Yes

Clear

Miller Enema Air Tip with Non-Latex Retention Cuff - 10815112020962 Catalog Number : 901201

Device Description : Non latex Retention Enema Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

Miller Enema Air Tip with Retention Cuff - 10815112020979 Catalog Number : 901202

Device Description : Non latex Air Retention Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

Super XL Enema System - 10815112020986 Catalog Number : 901203

Device Description : SXL w/Att. (Silicone Cuff)

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

Rounded Flexi Tip Adult Enema Tip - 10815112020993 Catalog Number : 901301

Device Description : Rounded Flexi Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

XL Flexi Tip: Adult Enema Tip - 10815112021006 Catalog Number : 901302

Device Description : XL Flexi Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

24 Fr Infant Flexi Tip: Pediatric Enema Tip - 10815112021013 Catalog Number : 901303

Device Description : Infant Flexi Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

Miller Enema Air Tip: Without Retention Cuff - 10815112021020 Catalog Number : 901304

Device Description : Miller Air Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

14 French Pediatric Flexi Tip - 10815112021037 Catalog Number : 901305

Device Description : 14 Fr Pediatric Flexi Tip

Device Class :

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 12

FLEXI-STOME Cone Colostomy Tip - 10815112021044 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

FLEXI-STOME Nipple Colostomy Tip - 10815112021051 Catalog Number : 901307

Device Description : Nipple Colostomy Tip

Device Class : 2

Duns Number: 849234661

Premarket Exempt : Yes

Product Code : FGD

Prescription Use : Yes

Device Count : 1

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