Catalog Number

5050.X00V0

Brand Name

HSW HENKE-JECT®

Version/Model Number

5050.X00V0

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

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

bb60bab5-971e-4af6-8c79-6c890376c61b

Public Version Date

December 27, 2019

Public Version Number

1

DI Record Publish Date

December 19, 2019

Package DI Number

04035873062844

Quantity per Package

20

Contains DI Package

04035873062837

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON