Catalog Number

-

Brand Name

Jelco

Version/Model Number

4244

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

742f22e8-db7e-4074-bf13-f7207426b3f2

Public Version Date

July 10, 2018

Public Version Number

4

DI Record Publish Date

January 17, 2017

Package DI Number

30351688044987

Quantity per Package

100

Contains DI Package

10351688044983

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX