McKesson - DRESSING, ANTIMICRO SLVR CALC - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: DRESSING, ANTIMICRO SLVR CALC

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

61-88582

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

K080497,K080497,K080497

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

bc1312c5-56b7-424e-bda8-cf8b572e33c1

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

June 10, 2020

Additional Identifiers

Package DI Number

40612479183313

Quantity per Package

48

Contains DI Package

20612479183302

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