Catalog Number

-

Brand Name

Plasti-Products

Version/Model Number

143020

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"

-

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

K970383,K970383,K970383

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

803289bb-b727-419f-ba6d-a56bb04cdf9c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 20, 2017

Package DI Number

40797876143013

Quantity per Package

2

Contains DI Package

20797876143019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case