Duns Number:021888258
Catalog Number
-
Brand Name
RtDosePlan
Version/Model Number
2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K022961
Product Code
MUJ
Product Code Name
System,Planning,Radiation Therapy Treatment
Public Device Record Key
a9024804-c560-44a8-9766-06f6c77dc14a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 17, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |