Catalog Number

MT6XSM1.7.4

Brand Name

Proutra™

Version/Model Number

MT6XSM1.7.4

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

K132084

Product Code

JAI

Product Code Name

Couch, radiation therapy, powered

Public Device Record Key

09d42208-15f0-493d-a0c8-7fbc31598b64

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

December 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-