Catalog Number

00860013000301

Brand Name

Wound Crown

Version/Model Number

00860013000301

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

EZS

Product Code Name

Appliance, Colostomy, Disposable

Public Device Record Key

b66b4f34-8dfa-491a-8b7d-52194cc1719a

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 20, 2022

Package DI Number

10860013000308

Quantity per Package

10

Contains DI Package

00860013000301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case