Catalog Number

9458900031

Brand Name

Owandy Radiology

Version/Model Number

Owandy-CR

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

K133271

Product Code

MUH

Product Code Name

System,X-Ray,Extraoral Source,Digital

Public Device Record Key

3e88fbcf-964c-4e05-b88a-46127474ecb7

Public Version Date

February 28, 2020

Public Version Number

1

DI Record Publish Date

February 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-