FDA.reportPublic FDA data

TheraSphere™

Primary DI
00191506025571
Brand
TheraSphere™
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00139553CEA0
Catalog number
M00139553CEA0
Device description
Administration set
Published
2026-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IWJSystem, applicator, radionuclide, manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWJSystem, Applicator, Radionuclide, ManualRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506025588PackageGS15In Commercial Distribution
00191506025571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506025588001915060255881915060255880191506025588
00191506025571001915060255711915060255710191506025571

GMDN Terms#

Term, Definition table
TermDefinition
Manual-afterloading brachytherapy system source delivery procedure kitA collection of sterile devices intended to dispense/collect hydraulic fluid used to deliver the radiation source train of a manual-afterloading brachytherapy system source transfer device to/from the delivery catheter/applicator. It consists of disposable devices such as syringes, fluid collection bags, adaptors/connectors. This is a single-use device.

Regulatory Flags#

DUNS number
021717889
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00191506062514Navigator™M0062504000M00625040002026-09-25
00191506062521Navigator™M0062504010M00625040102026-09-25
00191506062538Navigator™M0062504020M00625040202026-09-25
00191506062545Navigator™M0062504100M00625041002026-09-25
00191506062552Navigator™M0062504110M00625041102026-09-25
00191506062569Navigator™M0062504120M00625041202026-09-25
00191506062576Navigator™M0062504200M00625042002026-09-25
00191506062583Navigator™M0062504210M00625042102026-09-25
00191506062590Navigator™M0062504220M00625042202026-09-25
00802526531101ENDOTAK RELIANCE® S013701372014-09-24
00802526531118ENDOTAK RELIANCE® S013801382014-09-24
00802526531125ENDOTAK RELIANCE®015701572014-09-24
00802526531132ENDOTAK RELIANCE®015801582014-09-24
00191506047832NAM001AJAEC0100M001AJAEC01002026-09-22
00191506063214OPAL HDx™M004OPAL11020M004OPAL110202026-09-20
08714729972860LumiCoil™M005538302018-02-15
08714729972884LumiCoil™M005538402018-02-15
08714729842088Rhythmia™ Mapping SystemM004RH200002017-06-14
08714729842095Rhythmia™ Mapping SystemM004RH210002017-06-14
08714729842101Rhythmia™ Mapping SystemM004RH220002017-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B16556440328083126176Implant NeedleLiberty Medical , Inc.IWJ2026-08-18
B16556450328083126173Single Leader Catheter with LuerLiberty Medical , Inc.IWJ2026-08-18
B16556500328083126172Small Prostate TemplateLiberty Medical , Inc.IWJ2026-08-18
B16557060328083126147Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B1655765032802312606Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16558000328043026121Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-08-18
B16559100328083126175ButtonsLiberty Medical , Inc.IWJ2026-08-18
B16560390328023126165Single Leader Catheter with LuerLiberty Medical , Inc.IWJ2026-08-18
B16570160328083126144Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570170328083126159Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570170328083126174Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B1657017032808312646Flexi-NeedleLiberty Medical , Inc.IWJ2026-08-18
B16570550328083126017Gynecological TemplateLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126166AdapterLiberty Medical , Inc.IWJ2026-08-18
B16570940328083126177AdapterLiberty Medical , Inc.IWJ2026-08-18
00841365121593Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-08-03
00841365121609Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-08-03
00841436125451Classic StepperCIVCO MEDICAL INSTRUMENTS CO., INC.IWJ2026-07-23
B16556052032806302620Large Prostate TemplateLiberty Medical , Inc.IWJ2026-07-08
B16556510328063026080Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-07-08
B16556630328063026137Intrauterine TandemLiberty Medical , Inc.IWJ2026-07-08
B16557060328060026140Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B16558000327103126049Small Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558010328043026108Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-07-08
B16558100328103126034Small Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-07-08
B16559070328063026073ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559080328063026059ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16559100328063026111ButtonsLiberty Medical , Inc.IWJ2026-07-08
B16570160328063026139Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08
B1657060328063026115Flexi-NeedleLiberty Medical , Inc.IWJ2026-07-08