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Isolator Strip

FDA UDI

Class I (US FDA UDI)

by Fistula Solution Corporation

Identity

Trade Name
Isolator Strip FDA UDI
Generic Name
Ostomy convexity insert FDA UDI
Model / Reference
00860013000318 FDA UDI

Identifiers

Catalog Number
00860013000318 FDA UDI
Primary DI / UDI-DI
00860013000318 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

Isolator Strip 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 5b5631b9-289e-4347-a840-cf0c31d3721b 33 fields · synced May 30, 2026