Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-N2558S

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

fd102b26-84ac-499d-add4-9955c83928a3

Public Version Date

December 02, 2019

Public Version Number

1

DI Record Publish Date

November 22, 2019

Package DI Number

40612479244670

Quantity per Package

16

Contains DI Package

20612479244669

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case