Catalog Number

-

Brand Name

Jelco

Version/Model Number

4139

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

K946289,K946289,K946289

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

777fdbbe-e071-4af7-b2d9-c69f18754f79

Public Version Date

October 16, 2018

Public Version Number

5

DI Record Publish Date

July 05, 2017

Package DI Number

30351688041856

Quantity per Package

10

Contains DI Package

10351688041852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case