Catalog Number

AEU-525CFH

Brand Name

Aseptico

Version/Model Number

AEU-525CFH

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

47ac930a-e5b5-492d-9e4a-eb4dc15cd661

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-