Catalog Number

19001

Brand Name

Astek

Version/Model Number

19001

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"

Yes

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

JEP

Product Code Name

RETAINER, MATRIX

Public Device Record Key

9d71c248-3a37-4496-8856-344ab1656356

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

10843471150082

Quantity per Package

50

Contains DI Package

00843471150085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Package