Catalog Number

31-0605-0116

Brand Name

ATLAS Cart

Version/Model Number

ATLAS Cart

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code

OMC

Product Code Name

Reduced- Montage Standard Electroencephalograph

Public Device Record Key

5c3f84a7-313e-4331-9fc2-77ee6b7cf07f

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-