FDA.reportPublic FDA data

Blu Build Real Time Loader Device

Primary DI
M748BBL10
Brand
Blu Build Real Time Loader Device
Company
ISORAY MEDICAL, INC.
Model
BBL-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
M748BBL10PrimaryHIBCC0

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
M748BBC10Blu Build Spacer CartridgeBBC-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

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Primary DI, Brand, Company table
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