Catalog Number

33534T

Brand Name

Kendall

Version/Model Number

33534T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

IKD

Product Code Name

CABLE, ELECTRODE

Public Device Record Key

25395264-6fc8-412f-bba4-2b14d6ee3979

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

20884521212555

Quantity per Package

120

Contains DI Package

10884521212558

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE