Duns Number:222870839
Device Description: For use with a TheraSphere Administration Set to administer TheraSphere Y90 Glass Microsph For use with a TheraSphere Administration Set to administer TheraSphere Y90 Glass Microspheres
Catalog Number
-
Brand Name
TheraSphere Administration Accessory Kit (US)
Version/Model Number
K125914-001
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
-
Product Code
NAW
Product Code Name
Microspheres Radionuclide
Public Device Record Key
b92ce664-b432-4b39-9a9e-2cdc543134b9
Public Version Date
September 29, 2021
Public Version Number
2
DI Record Publish Date
June 19, 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. | 9 |
| 3 | A medical device with high risk that requires premarket approval | 73 |