Catalog Number

9251

Brand Name

Kendall

Version/Model Number

9251

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)

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

e991bcd0-b716-40c6-aadb-cb61ab6e82d5

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 27, 2018

Package DI Number

30884521007608

Quantity per Package

12

Contains DI Package

10884521007604

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE