Duns Number:415269930
Device Description: Oncentra External Beam 4.5.3/Oncentra Brachy v4.6
Catalog Number
-
Brand Name
NA
Version/Model Number
170018-00
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
K121448,K132816,K121448,K132816,K121448,K132816
Product Code
MUJ
Product Code Name
System, planning, radiation therapy treatment
Public Device Record Key
0986db3b-c947-4776-9d21-bd96e574cc75
Public Version Date
February 06, 2019
Public Version Number
2
DI Record Publish Date
December 19, 2018
Package DI Number
08717213054004
Quantity per Package
1
Contains DI Package
08717213053700
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1904 |