Catalog Number

-

Brand Name

PRONOVA SC360

Version/Model Number

R1.0

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

K162246

Product Code

LHN

Product Code Name

System, Radiation Therapy, Charged-Particle, Medical

Public Device Record Key

aaaedcc4-1118-4636-b684-f1f0cc0ab5e7

Public Version Date

October 10, 2018

Public Version Number

3

DI Record Publish Date

February 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-