McKesson - Foam, PHMB ADH w/ Border Sacral - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: Foam, PHMB ADH w/ Border Sacral

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

4977

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181197,K181197,K181197

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

14a763e3-e79e-488c-8c58-02891748c5fe

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 12, 2019

Additional Identifiers

Package DI Number

00612479243415

Quantity per Package

10

Contains DI Package

00612479243408

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