FDA.reportPublic FDA data

Proxcelan™ Cs-131 Preloaded Braided Strands

Primary DI
M748PL5M0
Brand
Proxcelan™ Cs-131 Preloaded Braided Strands
Company
ISORAY MEDICAL, INC.
Model
PL-5M
Published
2015-10-28
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M748PL5M0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, manualA general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113577485
Device count
1
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
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
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
M74881600Cesitrex™ 81602015-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M936IIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
M936IRLS15SSS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.KXK2024-07-15
B887MRTLS050515200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03
B887MRTLS075515180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03
M936IRLS20S9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
M936IRLS20SS9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
008152120213362PK 0.8X3.0MM GOLD FIDUCIAL LOOSEIzi Medical Products, LLCKXK2021-10-15
10801741184120SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
10801741184137SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
00813787021799TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021805TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021812TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021829TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021843TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021850TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021867TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021836TheragenicsTHERAGENICS CORPORATIONKXK2020-07-08
00853162006430Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006447Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006577Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006607Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
B887MRTL050415200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL050415210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL050820210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075415190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075820190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTLS075920180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887PTTL050110210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887TL050215200VISICOILIzi Medical Products, LLCKXK2020-04-30