Catalog Number

-

Brand Name

McKesson

Version/Model Number

19-16012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code

KDC

Product Code Name

Instrument, Surgical, Disposable

Public Device Record Key

50f20120-7dfe-4031-a3c8-983466f5cea2

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Package DI Number

40612479137996

Quantity per Package

10

Contains DI Package

20612479137985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case