Catalog Number

-

Brand Name

Jelco

Version/Model Number

G1790

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

K923127,K923127,K923127

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

d19cebe3-cca8-4c06-92b4-499cbd95b034

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

January 06, 2017

Package DI Number

55019517053102

Quantity per Package

8

Contains DI Package

35019517053108

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE