Catalog Number

4710008025

Brand Name

HSW HENKE-JECT®

Version/Model Number

4710008025

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

88f7a514-6f7a-4273-8f74-358029e7b2a9

Public Version Date

December 17, 2020

Public Version Number

1

DI Record Publish Date

December 09, 2020

Package DI Number

04035873058991

Quantity per Package

30

Contains DI Package

04035873058984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON