Catalog Number

3354C

Brand Name

Kendall

Version/Model Number

3354C

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

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

0ddeeea3-5df9-4f1b-89f2-01583e1ef812

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

20884521138848

Quantity per Package

48

Contains DI Package

10884521138841

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE