Duns Number:016853348
Device Description: AEU-350 Portable Dentistry System
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
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 21 |