Duns Number:080397923
Device Description: VERSABOARD ACCESSORY ADAPTER
Catalog Number
HNRT-7045
Brand Name
BIONIX RADIATION THERAPY
Version/Model Number
HNRT-7045
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 30, 2020
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
-
Product Code
IYE
Product Code Name
Accelerator, linear, medical
Public Device Record Key
ab8c3198-c5b6-412b-ad00-df81e99fc6d7
Public Version Date
March 26, 2021
Public Version Number
4
DI Record Publish Date
December 07, 2018
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |