Catalog Number

GX340-CL-BK-P

Brand Name

RadiForce®

Version/Model Number

GX340

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

K113784,K113784

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

9e3bcdda-1806-486e-b230-77a6fc6d82b9

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

14995047040252

Quantity per Package

2

Contains DI Package

04995047040255

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box