Catalog Number

8300022134

Brand Name

HSW HENKE-JECT®

Version/Model Number

8300022134

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

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

7e325f8e-83f3-4b71-be3c-06ca16f3b1b5

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

March 26, 2019

Package DI Number

04035873061014

Quantity per Package

40

Contains DI Package

04035873061007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON