Catalog Number

-

Brand Name

Kendall

Version/Model Number

5330

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K012417,K012417

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Public Device Record Key

8e69cc8e-020a-4a52-b8e8-4834004a9df5

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

30817357022064

Quantity per Package

5

Contains DI Package

10817357022060

Package Discontinue Date

March 19, 2021

Package Status

Not in Commercial Distribution

Package Type

Box