Catalog Number

4606701V-02

Brand Name

INJEKT™

Version/Model Number

4606701V-02

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

f8c26d20-a3f0-491e-acb6-4d6937ec4a68

Public Version Date

August 11, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

04046964002656

Quantity per Package

25

Contains DI Package

04046964002649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton