Catalog Number

AEU-525

Brand Name

Aseptico

Version/Model Number

AEU-525

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

September 30, 2031

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

59e8b3e7-a0d8-4e8d-9fea-b66c2a5da2a2

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-