Duns Number:355977901
Catalog Number
-
Brand Name
RayCare
Version/Model Number
3.1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 09, 2022
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
K200487
Product Code
MUJ
Product Code Name
System, Planning, Radiation Therapy Treatment
Public Device Record Key
c15f70f5-c55e-4695-be54-a3ba3bc3b336
Public Version Date
June 01, 2022
Public Version Number
2
DI Record Publish Date
August 24, 2020
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. | 33 |