Catalog Number

-

Brand Name

TheraSphere Y90 Glass Microspheres 20.0 GBq (US Commercial)

Version/Model Number

OTT-SPE-FP-700 (990700.SPE)

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

381b7597-3bd5-4b4c-9680-d8fbbadba77d

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

-