Duns Number:222870839
Device Description: Administration Set to be used for infusion of TheraSphere Y90 Glass Microspheres
Catalog Number
-
Brand Name
TheraSphere Administration Set
Version/Model Number
OTT-SPE-FP-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
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
NAW
Product Code Name
Microspheres Radionuclide
Public Device Record Key
7182fc2f-39f0-4238-9d0f-00e43cc6f4e9
Public Version Date
September 29, 2021
Public Version Number
2
DI Record Publish Date
November 01, 2018
Package DI Number
05060116920659
Quantity per Package
20
Contains DI Package
05060116920642
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Box
| 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 |