Catalog Number

RX560-BK-MD

Brand Name

RadiForce®

Version/Model Number

RX560

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

K172738,K172738

Product Code

PGY

Product Code Name

Display, Diagnostic Radiology

Public Device Record Key

294cc9fa-656f-4349-9836-173d8dd91357

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

November 16, 2017

Package DI Number

14995047051401

Quantity per Package

2

Contains DI Package

04995047051404

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box