Catalog Number

8884476139

Brand Name

Kendall

Version/Model Number

8884476139

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MGQ

Product Code Name

Dressing, wound and burn, hydrogel w/drug and/or biologic

Public Device Record Key

05c7a27e-66b0-48aa-887d-e16dff2b868f

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 27, 2018

Package DI Number

20884521057941

Quantity per Package

5

Contains DI Package

40884521057945

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK