Kendall - Calcium Alginate Dressing,Rope - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Calcium Alginate Dressing,Rope

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More Product Details

Catalog Number

9243

Brand Name

Kendall

Version/Model Number

9243

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KMF

Product Code Name

Bandage, liquid

Device Record Status

Public Device Record Key

34880002-1e9f-47a1-8491-00c4acafce86

Public Version Date

July 22, 2021

Public Version Number

5

DI Record Publish Date

June 27, 2018

Additional Identifiers

Package DI Number

40884521025012

Quantity per Package

20

Contains DI Package

10884521025011

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