Catalog Number

MT6XCALS

Brand Name

Proutra™

Version/Model Number

MT6XCALS

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

K031866

Product Code

JAI

Product Code Name

Couch, radiation therapy, powered

Public Device Record Key

af272b87-fd4d-4f28-9242-24f8c7c6407f

Public Version Date

June 17, 2019

Public Version Number

7

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-