Catalog Number

5022S000V0

Brand Name

HSW SOFT-JECT®

Version/Model Number

5022S000V0

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

46a73b5f-6e58-4359-a5eb-b852dbb1672b

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 05, 2016

Package DI Number

04035873015871

Quantity per Package

25

Contains DI Package

04035873015888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON