ESTEEM+ - Esteem®+ Moldable One-Piece Drainable Pouch W/ - CONVATEC, PURCHASING DEPARTMENT

Duns Number:809784593

Device Description: Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided W Esteem®+ Moldable One-Piece Drainable Pouch W/ Inviclose, Filter, Stomahesive, Two-Sided Window Comfort Panel 12" Opaque, (40/50M

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More Product Details

Catalog Number

-

Brand Name

ESTEEM+

Version/Model Number

413523

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EXH

Product Code Name

BAG, URINARY, ILEOSTOMY

Device Record Status

Public Device Record Key

0c737c97-5392-43af-8873-9cc44efd0275

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Additional Identifiers

Package DI Number

10768455130259

Quantity per Package

14

Contains DI Package

00768455130252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CONVATEC, PURCHASING DEPARTMENT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 116
U Unclassified 8