Catalog Number

GS220-CL-BK-P

Brand Name

RadiForce®

Version/Model Number

GS220

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

K070131,K070131

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Public Device Record Key

57e26c07-50cb-432b-9003-13b3bdb43a4d

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

14995047020568

Quantity per Package

2

Contains DI Package

04995047020561

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box