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FLEXI-STOME Cone Colostomy Tip

FDA UDI

Class II (US FDA UDI)

by Bracco Diagnostics Inc.

Identity

Trade Name
FLEXI-STOME Cone Colostomy Tip FDA UDI
Generic Name
Barium enema catheter FDA UDI
Device Name
Cone Colostomy Tip FDA UDI
Model / Reference
901306 FDA UDI
Description
Cone Colostomy Tip FDA UDI

Identifiers

Catalog Number
901306 FDA UDI
Primary DI / UDI-DI
10815112021655 FDA UDI
FDA Product Code
FGD FDA UDI
GMDN Term
Barium enema catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5980 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Barium enema catheter

FLEXI-STOME Cone Colostomy Tip by Bracco Diagnostics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Barium enema catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bracco Diagnostics Inc.

Sources (1)

  • FDA UDI f638a8b6-b945-431b-b161-5aea793e3c67 35 fields · synced May 30, 2026