FDA.reportPublic FDA data

BMT Cleaning Brush Set, Vertical Lock

Primary DI
00860003072745
Brand
BMT Cleaning Brush Set, Vertical Lock
Company
CONCURE ONCOLOGY, INC.
Model
AC-B30505
Published
2020-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00860003072745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003072745008600030727458600030727450860003072745

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy systemAn assembly of therapeutic, independent devices, manually brought together and intended to deliver a palliative or therapeutic radiation dose to an anatomical region from radionuclide sources. Medical personnel manually place multiple radioactive sources in appliances and applicators for either permanent or temporary delivery at the topical, interstitial, intraluminal, or intracavitary brachytherapy treatment site. The radioactive source(s) assemblies contain naturally occurring, reactor produced, or accelerator produced radionuclides that are in the form of, e.g., encapsulated, embedded, sealed, wire, plated or foil sources, contained radioactive liquids, gels or gas.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056124661
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003072776BMT Breast ShieldAC-B31102020-08-05
00860005821204Obturator and Caps5303122021-04-19
00860005821211BMT Localizer Needle KitAC-B50002021-04-19
00860003072714BMT Template Grid Armature & Table ClampAC-B30302020-08-05
00860003072721BMT Armrest Armature & Table ClampAC-B30402020-08-05
00860003072738BMT Template Grid, Vertical Lock, LargeAC-B302052020-08-05
00860003072752BMT Fiducial Needle, Sharp97-FN17202020-08-05
00860003072769BMT Fiducial Needle, Round80-FN17202020-08-05

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Primary DI, Brand, Company table
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B165580203270931260031Large Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
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B16559060328043026048ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16559070328043025007ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16570160328043026056Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
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