McKesson - Hydrogel Amorphous Wound Dressing - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: Hydrogel Amorphous Wound Dressing

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

1722

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

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

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Device Record Status

Public Device Record Key

c38ba21d-54b6-4f92-97fd-5bd79e68a04c

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Additional Identifiers

Package DI Number

00612479193314

Quantity per Package

12

Contains DI Package

00612479193307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"MCKESSON MEDICAL-SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 870
2 A medical device with a moderate to high risk that requires special controls. 422
U Unclassified 44