Catalog Number

-

Brand Name

Equate

Version/Model Number

557642344 (F414-436WM)

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

d3fd9f4d-dae4-41c3-abe2-33e563dcd662

Public Version Date

September 24, 2020

Public Version Number

1

DI Record Publish Date

September 16, 2020

Package DI Number

20681131161767

Quantity per Package

6

Contains DI Package

00681131161763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner