Catalog Number

-

Brand Name

STERiJECT TM

Version/Model Number

PRE-27013IP

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

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

25d9f504-5906-4933-9ad7-2685f5c1cd2c

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

September 17, 2016

Package DI Number

14571225315420

Quantity per Package

48

Contains DI Package

04571225315423

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton