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Esteem+

FDA UDI

Class I (US FDA UDI)

by Convatec, Purchasing Department

Identity

Trade Name
ESTEEM+ FDA UDI
Generic Name
One-piece intestinal ostomy bag, open-ended FDA UDI
Device Name
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/8" (35Mm) FDA UDI
Model / Reference
416749 FDA UDI
Description
Esteem®+ Convex One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Durahesive®, One-Sided Comfort Panel 12" Opaque, 1 3/8" (35Mm) FDA UDI

Identifiers

Primary DI / UDI-DI
00768455112197 FDA UDI
FDA Product Code
FON FDA UDI
GMDN Term
One-piece intestinal ostomy bag, open-ended 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: One-piece intestinal ostomy bag, open-ended

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

Similar devices

Also classified as One-piece intestinal ostomy bag, open-ended.

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 acf969ec-43ec-4b9f-ba27-b1239c96deee 34 fields · synced Jun 8, 2026