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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 urostomy bag, open-ended FDA UDI
Device Name
Esteem®+ Flex Convex, One Piece Urostomy System, Drainable, V1 Cut-To-Fit, 10-43Mm, FDA UDI
Model / Reference
421623 FDA UDI
Description
Esteem®+ Flex Convex, One Piece Urostomy System, Drainable, V1 Cut-To-Fit, 10-43Mm, FDA UDI

Identifiers

Primary DI / UDI-DI
00768455143375 FDA UDI
FDA Product Code
EXG FDA UDI
GMDN Term
One-piece urostomy 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

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

No

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 urostomy 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 urostomy 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 eb2eac10-dabb-4d5b-8726-fd2c7e381eb8 34 fields · synced May 31, 2026