Catalog Number

206XPIPS3

Brand Name

Protura

Version/Model Number

206XPIPS3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2019

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

8f41dc0b-49be-4de0-a561-9394c2aeb4f7

Public Version Date

August 11, 2022

Public Version Number

6

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-