FDA.reportPublic FDA data

Cesitrex™

Primary DI
M74881600
Brand
Cesitrex™
Company
ISORAY MEDICAL, INC.
Model
8160
Published
2015-10-28
Public version status
Update
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
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132996000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132996000CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTSIsoray, Inc.2013-12-17KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M74881600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Brain brachytherapy system applicator, manualA device specifically designed to be used in radiation therapy treatments of the brain. It has individual or modular device configurations designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging guided placement, and removal of single or multiple radioactive sources at a treatment site within the brain. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes brain applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.

Regulatory Flags#

DUNS number
113577485
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M748BBC10Blu Build Spacer CartridgeBBC-12018-10-26
M748BBL10Blu Build Real Time Loader DeviceBBL-12018-10-26
M748BBS10Blu Build Sleeve CarrierBBS-12018-10-26
M748CS10Proxcelan™ Cs-131 Brachytherapy Seeds CS-12015-10-28
M748CS1NS0Proxcelan™ Cs-131 Brachytherapy Seeds CS-1NS2015-10-28
M748PL10Proxcelan™ Cs-131 StrandsPL-12015-10-28
M748PL20Proxcelan™ Cs-131 Preloaded Strands in 18G NeedlesPL-22015-10-28
M748PL30Proxcelan™ Cs-131 Preloaded 18G NeedlesPL-32015-10-28
M748PL40Proxcelan™ Cs-131 Preloaded S-CartridgesPL-42015-10-28
M748PL4NS0Proxcelan™ Cs-131 Preloaded Mick® Cartridges - Non SterilePL-4NS2015-10-28
M748PL50Proxcelan™ Cs-131 Preloaded Braided StrandsPL-52015-10-28
M748PL5M0Proxcelan™ Cs-131 Preloaded Braided StrandsPL-5M2015-10-28
M748BB11Strand CutterBB-12023-09-25
M748PL70PL-7 Cs-131 Brachytherapy Seeds in Preloaded Strands with MRI MarkersPL-72021-04-23
M748PL80PL-8 Cs-131 Brachytherapy Seeds Preloaded Strands in 18G Needles with MRI MarkerPL-82021-04-23
M748BB10Blu Blade BB-12019-03-28
M74810200GliaSite® Catheter Tray10202015-10-28
M74810300GliaSite® Catheter Tray10302015-10-28
M74810400GliaSite® Catheter Tray10402015-10-28
M74881500Iotrex® 81502015-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M936IIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
M936PDIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
00841365121531Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2026-05-04
00841365121500Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2026-04-03
00841365121425Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-12-16
00841365121388Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-10-20
M936IRLS15SSS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
M936IRLS15S9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
M936IRLS15SS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.KXK2024-07-15
00860000064545GammaTileGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
20860000064549GammaTileGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064569CS-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064576CS-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064583PL-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064590PL-5GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485407PL-2GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485414PL-3GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485421PL-4GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485438PL-4NSGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485445PL-5MGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485452PL-7GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485469PL-8GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00841365120688Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2024-03-14
00841365120640Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2024-01-29
00850800006067VariSeedVARIAN MEDICAL SYSTEMS, INC.KXK2023-09-15
00841365120503Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-08-21
00841365120510Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-08-21
00841365120213Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-03-29
B887MRTLS050515200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03