Catalog Number

5300.X00D0

Brand Name

HSW SOFT-JECT®

Version/Model Number

5300.X00D0

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

c5164b70-348f-47f6-8309-8060ea8edaea

Public Version Date

July 13, 2018

Public Version Number

3

DI Record Publish Date

September 05, 2016

Package DI Number

04035873008682

Quantity per Package

10

Contains DI Package

04035873008699

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON