← Back to catalogue

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, V3 Pre-Cut, 15Mm FDA UDI
Model / Reference
421629 FDA UDI
Description
Esteem®+ Flex Convex, One Piece Urostomy System, Drainable, V3 Pre-Cut, 15Mm FDA UDI

Identifiers

Primary DI / UDI-DI
00768455143498 FDA UDI
FDA Product Code
EXH 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

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 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Convatec, Purchasing Department

Sources (1)

  • FDA UDI 0e00cc99-527a-4905-8a46-fda92fa0859c 34 fields · synced May 30, 2026