Catalog Number

AEU-350

Brand Name

Aseptico

Version/Model Number

AEU-350

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 31, 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

K130693

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

6edf2f4e-1f5b-46fc-b507-2b86ee2cb307

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-