Catalog Number

-

Brand Name

STERiJECT TM

Version/Model Number

HPC-30013E

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"

-

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

K970370,K970370,K970370,K970370

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

ee231104-f389-421d-8424-560239aebc60

Public Version Date

December 15, 2020

Public Version Number

2

DI Record Publish Date

November 20, 2020

Package DI Number

14571225317592

Quantity per Package

10

Contains DI Package

04571225317595

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-