Catalog Number

33112G

Brand Name

Kendall

Version/Model Number

33112G

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

Yes

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

6c396998-fb37-4e9b-b0fa-13752889f9ec

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

June 23, 2017

Package DI Number

30884521621477

Quantity per Package

100

Contains DI Package

10884521621473

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE