Catalog Number

31286548A

Brand Name

Kendall

Version/Model Number

31286548A

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

aadd8589-cb96-4195-b4f1-e6d33e669c7a

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884521148987

Quantity per Package

10

Contains DI Package

20884521148984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE