FDA.reportPublic FDA data

Medium Prostate Brachytherapy Kit

Primary DI
B16558010326123125031
Brand
Medium Prostate Brachytherapy Kit
Company
Liberty Medical , Inc.
Model
5801
Device description
The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy
Published
2025-05-05
Public version status
New
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
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
B16558010326123125031PrimaryHIBCC0

GMDN Terms#

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

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge15Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
967592978
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B16556440328083126176Implant Needle56442026-08-18
B16556450328083126173Single Leader Catheter with Luer60392026-08-18
B16556500328083126172Small Prostate Template56502026-08-18
B16557060328083126147Flexi-Needle57062026-08-18
B1655765032802312606Flexi-Needle57652026-08-18
B16558000328043026121Small Prostate Brachytherapy Kit58002026-08-18
B16559100328083126175Buttons59102026-08-18
B16560390328023126165Single Leader Catheter with Luer60392026-08-18
B16570160328083126144Flexi-Needle70162026-08-18
B16570170328083126159Flexi-Needle70172026-08-18
B16570170328083126174Flexi-Needle70172026-08-18
B1657017032808312646Flexi-Needle70172026-08-18
B16570550328083126017Gynecological Template70552026-08-18
B16570940328083126166Adapter70942026-08-18
B16570940328083126177Adapter70942026-08-18
B16556052032806302620Large Prostate Template56522026-07-08
B16556510328063026080Medium Prostate Template56512026-07-08
B16556630328063026137Intrauterine Tandem56632026-07-08
B16557060328060026140Flexi-Needle57062026-07-08
B16558000327103126049Small Prostate Brachytherapy Kit58002026-07-08

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