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Esenta

FDA UDI

Class I (US FDA UDI)

by Convatec, Purchasing Department

Identity

Trade Name
ESENTA FDA UDI
Generic Name
Intestinal stoma shield/support belt, single-use FDA UDI
Device Name
ESENTA THIN XL SEMI CIRCLE (1X20PK) EUR FDA UDI
Model / Reference
423827 FDA UDI
Description
ESENTA THIN XL SEMI CIRCLE (1X20PK) EUR FDA UDI

Identifiers

Primary DI / UDI-DI
00768455209484 FDA UDI
FDA Product Code
EXE FDA UDI
GMDN Term
Intestinal stoma shield/support belt, single-use 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: Intestinal stoma shield/support belt, single-use

Esenta by Convatec, Purchasing Department — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intestinal stoma shield/support belt, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Convatec, Purchasing Department

Sources (1)

  • FDA UDI ed53ed26-47c7-4115-bf06-382bd2ecb913 34 fields · synced May 30, 2026