Catalog Number

-

Brand Name

ATOMO

Version/Model Number

AA0021

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

a7d53633-4c3d-423c-91f6-ab95ab0bf566

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Package DI Number

D883AA00213

Quantity per Package

10

Contains DI Package

D883AA00211

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton