Catalog Number

-

Brand Name

Jelco

Version/Model Number

402310

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

K041399,K041399,K041399

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

050b76d5-2ace-4e80-bbf2-c80ec6da9ec4

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

July 05, 2017

Package DI Number

30351688066521

Quantity per Package

10

Contains DI Package

10351688066527

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE