McKesson - CATH TRAY, URETH PLAS (20/CS) - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: CATH TRAY, URETH PLAS (20/CS)

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

37-231

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

K904158,K904158

Product Code Details

Product Code

FCM

Product Code Name

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Device Record Status

Public Device Record Key

81fdf8da-91e5-42ed-a72d-f452dd9932f1

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

40612479115178

Quantity per Package

20

Contains DI Package

20612479101320

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