Catalog Number

-

Brand Name

NA

Version/Model Number

Sterile

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

EXH

Product Code Name

Bag, Urinary, Ileostomy

Public Device Record Key

bbbf994f-2a6e-441f-9bea-a14d24549b92

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 03, 2022

Package DI Number

16974795050216

Quantity per Package

40

Contains DI Package

06974795050219

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-