Catalog Number

-

Brand Name

AutoTouch reusable autoinjector

Version/Model Number

9003600

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

NSC

Product Code Name

Injector, Pen

Public Device Record Key

f9d908e5-7c28-4cdb-bb25-002f83ac2c0e

Public Version Date

October 02, 2019

Public Version Number

1

DI Record Publish Date

September 24, 2019

Package DI Number

10358406470017

Quantity per Package

15

Contains DI Package

00358406470010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case