Protura 1.7.2 - Protura™ Robotic Couch System Version 1.7.2 - MEDTEC, INC.

Duns Number:103977526

Device Description: Protura™ Robotic Couch System Version 1.7.2

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More Product Details

Catalog Number

MT6XSM1.7.2

Brand Name

Protura 1.7.2

Version/Model Number

MT6XSM1.7.2

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 07, 2018

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

JAI

Product Code Name

Couch, radiation therapy, powered

Device Record Status

Public Device Record Key

3003094a-fe5d-48db-9c40-199db3d37ea4

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 02, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 1027