Catalog Number

AEU-28KER

Brand Name

KERR

Version/Model Number

AEU-28KER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

March 31, 2032

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

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Public Device Record Key

6b667931-46c2-4b60-882b-a54836b4bec5

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-