TheraSphere Y90 Glass Microspheres 13.0 GBq - TheraSphere Yttrium-90 Glass Microspheres 13.0 - BIOCOMPATIBLES UK LTD

Duns Number:222870839

Device Description: TheraSphere Yttrium-90 Glass Microspheres 13.0 GBq Dose

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More Product Details

Catalog Number

-

Brand Name

TheraSphere Y90 Glass Microspheres 13.0 GBq

Version/Model Number

990700.SPE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 22, 2020

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

NAW

Product Code Name

Microspheres Radionuclide

Device Record Status

Public Device Record Key

c3a00d67-18eb-40ad-90ea-d69555c87b0d

Public Version Date

September 29, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCOMPATIBLES UK LTD" Characteristics
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