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Fistula Funnel

FDA UDI

Class I (US FDA UDI)

by Fistula Solution Corporation

Identity

Trade Name
Fistula Funnel FDA UDI
Generic Name
Ostomy convexity insert FDA UDI
Model / Reference
00860013000325 FDA UDI

Identifiers

Catalog Number
00860013000325 FDA UDI
Primary DI / UDI-DI
00860013000325 FDA UDI
FDA Product Code
EZS FDA UDI
GMDN Term
Ostomy convexity insert FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.5900 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

No

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: Ostomy convexity insert

Fistula Funnel by Fistula Solution Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ostomy convexity insert.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fistula Solution Corporation

Sources (1)

  • FDA UDI 54691bee-55df-4a4a-a66a-d45a81be7d9f 33 fields · synced Jun 1, 2026