Catalog Number

-

Brand Name

Jelco

Version/Model Number

972306

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

K895705,K895705,K895705

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

4aff421a-ab43-401f-bbd1-0d86a6b5b046

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

January 12, 2017

Package DI Number

30351688059974

Quantity per Package

4

Contains DI Package

10351688059970

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE