Catalog Number

-

Brand Name

ATOMO

Version/Model Number

AA1243

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

NRD

Product Code Name

Unit, Operative Dental, Accessories

Public Device Record Key

f1a3993e-c056-4117-b122-e744f988a30a

Public Version Date

September 13, 2022

Public Version Number

1

DI Record Publish Date

September 05, 2022

Package DI Number

D883AA12433

Quantity per Package

36

Contains DI Package

D883AA12431

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton