Catalog Number

-

Brand Name

ESTEEM+

Version/Model Number

422159

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

EZQ

Product Code Name

POUCH, COLOSTOMY

Public Device Record Key

8285deaf-66c3-4568-acb0-4752b1724af6

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Package DI Number

10768455152541

Quantity per Package

20

Contains DI Package

00768455152544

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-