Duns Number:080397923
Device Description: PELVIS BELLY: GEN3 PAD SET ASSEMBLY W/ MEDIUM AND SMALL INSERTS
Catalog Number
5105-00-03
Brand Name
BIONIX RADIATION THERAPY
Version/Model Number
5105-00-03
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 30, 2020
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
9f7d2aeb-3fce-49e5-88bc-85e2daf5be71
Public Version Date
December 30, 2020
Public Version Number
6
DI Record Publish Date
January 09, 2017
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 |