Kendall - Amorphous Hydrogel Wound Dressing - Cardinal Health, Inc.

Duns Number:080935429

Device Description: Amorphous Hydrogel Wound Dressing

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More Product Details

Catalog Number

9252

Brand Name

Kendall

Version/Model Number

9252

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

MGQ

Product Code Name

Dressing, wound and burn, hydrogel w/drug and/or biologic

Device Record Status

Public Device Record Key

7fe0b8b9-e2d6-425d-a702-bff14cd1f65b

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

June 27, 2018

Additional Identifiers

Package DI Number

30884521007615

Quantity per Package

12

Contains DI Package

10884521007611

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