Catalog Number

-

Brand Name

AutoTouch Connect reusable autoinjector

Version/Model Number

9006940

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

fc3559bf-b842-45cd-aa53-3628f625cd60

Public Version Date

November 16, 2021

Public Version Number

1

DI Record Publish Date

November 08, 2021

Package DI Number

10358406480016

Quantity per Package

15

Contains DI Package

00358406480019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case