Catalog Number

23046ASTEK

Brand Name

Astek

Version/Model Number

23046ASTEK

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EJI

Product Code Name

Syringe, cartridge

Public Device Record Key

b90bbf93-64fc-45b1-bc42-37f471acfb79

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

20843471151451

Quantity per Package

25

Contains DI Package

10843471151454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case