Duns Number:080397923
Device Description: 3.2MM HEAD ONLY VERSAFRAME
Catalog Number
EMRT-8340
Brand Name
BIONIX RADIATION THERAPY
Version/Model Number
EMRT-8340
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
Yes
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
262c8a34-3f15-4923-9dde-68de35ccffe9
Public Version Date
March 29, 2021
Public Version Number
4
DI Record Publish Date
April 25, 2017
Package DI Number
10817740020222
Quantity per Package
6
Contains DI Package
00817740020225
Package Discontinue Date
October 30, 2020
Package Status
Not in Commercial Distribution
Package Type
box
| 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 |