TheraSphere 360™ M00139509001

GUDID 00191506068264

Y-90 Management Platform

BOSTON SCIENTIFIC CORPORATION

Radiation therapy software
Primary Device ID00191506068264
NIH Device Record Key102f2d51-e053-4162-a54e-a8c137d14017
Commercial Distribution StatusIn Commercial Distribution
Brand NameTheraSphere 360™
Version Model NumberM00139509001
Catalog NumberM00139509001
Company DUNS021717889
Company NameBOSTON SCIENTIFIC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100191506068264 [Primary]

FDA Product Code

LLZSystem, image processing, radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-16
Device Publish Date2026-01-08

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