Catalog Number

-

Brand Name

RayCare

Version/Model Number

3.0.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 05, 2022

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

K191384

Product Code

MUJ

Product Code Name

System, Planning, Radiation Therapy Treatment

Public Device Record Key

b2c29f1f-4249-4f9e-9222-8abbd6b50485

Public Version Date

June 01, 2022

Public Version Number

2

DI Record Publish Date

August 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-