Kendall - Ultrasound Gel Bottle - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Ultrasound Gel Bottle

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More Product Details

Catalog Number

4060

Brand Name

Kendall

Version/Model Number

4060

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 18, 2021

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

-

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

MUI

Product Code Name

Media,coupling,ultrasound

Device Record Status

Public Device Record Key

10b69c83-34d0-4f73-86bf-0a49e1d62399

Public Version Date

June 10, 2022

Public Version Number

9

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20884527017284

Quantity per Package

12

Contains DI Package

30884527017281

Package Discontinue Date

February 18, 2021

Package Status

Not 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