Catalog Number

AJ1060

Brand Name

Autoject 2

Version/Model Number

AJ1060

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KZH

Product Code Name

Introducer, Syringe Needle

Public Device Record Key

82487a97-3134-43ab-82cc-4399324be3bc

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 19, 2016

Package DI Number

25016189106012

Quantity per Package

80

Contains DI Package

15016189106015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case