Catalog Number

-

Brand Name

ATOMO

Version/Model Number

AA0810

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EHY

Product Code Name

Tray, Impression, Preformed

Public Device Record Key

3e2ee356-c5a2-4f86-8275-ae9ad215f8a9

Public Version Date

September 15, 2022

Public Version Number

1

DI Record Publish Date

September 07, 2022

Package DI Number

D883AA08103

Quantity per Package

30

Contains DI Package

D883AA08101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton