Catalog Number

5010.A00V0

Brand Name

HSW HENKE-JECT®

Version/Model Number

5010.A00V0

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

08d8ce89-75ff-4e03-b2b4-0c6745d2b030

Public Version Date

December 16, 2020

Public Version Number

1

DI Record Publish Date

December 08, 2020

Package DI Number

04035873062301

Quantity per Package

18

Contains DI Package

04035873062295

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON