Catalog Number

GX560-ARBK

Brand Name

RadiForce®

Version/Model Number

GX560

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

K181609,K181609

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Public Device Record Key

8c73ad4a-9a92-462e-99a8-5ec576b02502

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

July 30, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-