Catalog Number

4582C

Brand Name

Kendall

Version/Model Number

4582C

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

5bea0860-3f6c-4e5a-ad10-a07145314e3e

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 29, 2018

Package DI Number

10884521084339

Quantity per Package

36

Contains DI Package

20884521084336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE