FDA.reportPublic FDA data

Medium Prostate Brachytherapy Kit

Primary DI
B16558010328010026067
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
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
B16558010328010026067PrimaryHIBCC0

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 Gauge0

Regulatory Flags#

DUNS number
967592978
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B16556330328053126035Flexi-Needle56332026-06-01
B1655635032805302533Implant Needle56352026-06-01
B1655662032805302615Intrauterine Tandem56622026-06-01
B16558010327123126103Medium Prostate Brachytherapy Kit58012026-06-01
B165580203270931260031Large Prostate Brachytherapy Kit58022026-06-01
B16558110328022826066Medium Prostate Brachytherapy Kit-metal hub58112026-06-01
B16559050328053126091Buttons59052026-06-01
B16559060328053026074Buttons59062026-06-01
B16559090328053026060Buttons59092026-06-01
B16559100328053026079Buttons59102026-06-01
B16570160328053126101Flexi-Needle70162026-06-01
B16570170328053126102Flexi-Needle70172026-06-01
B16570940328053126107Adapter70942026-06-01
B165565003280430252241Small Prostate Template56502026-05-01
B16556510328043026077Medium Prostate Template56512026-05-01
B165576403280430260101Flexi-Needle57642026-05-01
B16557640328043026081Flexi-Needle57642026-05-01
B16557650328040025244Flexi-Needle57652026-05-01
B16559060328043026048Buttons59062026-05-01
B16559070328043025007Buttons59072026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B16556330328053126035Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B1655635032805302533Implant NeedleLiberty Medical , Inc.IWJ2026-06-01
B1655662032805302615Intrauterine TandemLiberty Medical , Inc.IWJ2026-06-01
B16558010327123126103Medium Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B165580203270931260031Large Prostate Brachytherapy KitLiberty Medical , Inc.IWJ2026-06-01
B16558110328022826066Medium Prostate Brachytherapy Kit-metal hubLiberty Medical , Inc.IWJ2026-06-01
B16559050328053126091ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559060328053026074ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559090328053026060ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16559100328053026079ButtonsLiberty Medical , Inc.IWJ2026-06-01
B16570160328053126101Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570170328053126102Flexi-NeedleLiberty Medical , Inc.IWJ2026-06-01
B16570940328053126107AdapterLiberty Medical , Inc.IWJ2026-06-01
00841365121579Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-29
00841365121562Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-21
00841365121555Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-15
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.IWJ2026-05-11
00841365121548Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-05-06
B165565003280430252241Small Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B16556510328043026077Medium Prostate TemplateLiberty Medical , Inc.IWJ2026-05-01
B165576403280430260101Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557640328043026081Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16557650328040025244Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16559060328043026048ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16559070328043025007ButtonsLiberty Medical , Inc.IWJ2026-05-01
B16570160328043026056Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
B16570170328043026057Flexi-NeedleLiberty Medical , Inc.IWJ2026-05-01
00841365121524Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-04-29
00841365121517Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.IWJ2026-04-16
B16556320328033123181Flexi-NeedleLiberty Medical , Inc.IWJ2026-03-26