Catalog Number

-

Brand Name

McKesson

Version/Model Number

101-185

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K942054,K942054

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

20d37af6-0877-4a59-ab3c-cc8ee72fffe4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

40612479169218

Quantity per Package

20

Contains DI Package

10612479169200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case