Kendall - DL Disposable Lead Set - Cardinal Health, Inc.

Duns Number:080935429

Device Description: DL Disposable Lead Set

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More Product Details

Catalog Number

33136RT36R

Brand Name

Kendall

Version/Model Number

33136RT36R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IKD

Product Code Name

CABLE, ELECTRODE

Device Record Status

Public Device Record Key

632c93d3-0fcd-4786-a6be-352b26545a01

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

June 30, 2017

Additional Identifiers

Package DI Number

20884521516530

Quantity per Package

100

Contains DI Package

30884521516537

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"CARDINAL HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 672
2 A medical device with a moderate to high risk that requires special controls. 1692
U Unclassified 17