Catalog Number

9403

Brand Name

Kendall

Version/Model Number

9403

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

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

d68a0604-2713-4ba1-ba52-db73ac61c8f1

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 29, 2018

Package DI Number

00884521030926

Quantity per Package

50

Contains DI Package

10884521030893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE