Duns Number:103977526
Device Description: Protura Robotic Couch System Version 1.6.1
Catalog Number
MT6XSM1.6.1
Brand Name
Protura
Version/Model Number
MT6XSM1.6.1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 20, 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
138cdc9f-4802-4dc7-bf27-db9601fd29f1
Public Version Date
March 20, 2019
Public Version Number
4
DI Record Publish Date
August 02, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |