FDA.reportPublic FDA data

Blu Build Spacer Cartridge

Primary DI
M748BBC10
Brand
Blu Build Spacer Cartridge
Company
ISORAY MEDICAL, INC.
Model
BBC-1
Published
2018-10-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
M748BBC10PrimaryHIBCC0

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
Ethylene Oxide

Regulatory Flags#

DUNS number
113577485
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
M74881600Cesitrex™ 81602015-10-28

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