Catalog Number

AJ1311

Brand Name

Autoject 2

Version/Model Number

AJ1311

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

-

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

K993385,K993385

Product Code

KZH

Product Code Name

Introducer, Syringe Needle

Public Device Record Key

42b543ba-6fe9-479d-88d8-f5f1df8dfe9a

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

0384701311031

Quantity per Package

50

Contains DI Package

00384701311017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case