Catalog Number

-

Brand Name

Genoray

Version/Model Number

OSCAR 15

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K172180

Product Code

JAA

Product Code Name

System, X-Ray, Fluoroscopic, Image-Intensified

Public Device Record Key

d498267e-61a7-41dc-b7a5-0e402ac8d8a0

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-