Catalog Number

AEU-6000ADN

Brand Name

Aseptico

Version/Model Number

AEU-6000ADN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 01, 2030

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

K103399

Product Code

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Public Device Record Key

23b67f54-6268-4977-8095-09f49fb04039

Public Version Date

February 22, 2022

Public Version Number

1

DI Record Publish Date

February 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-