FDA.report

Brachytherapy source spacer

Definition
A sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour. It typically has a cylindrical form (of around 0.5 cm in length and less than 1 mm in diameter) and is made of bioabsorbable polymer materials. It may be used for the primary treatment of tumours (e.g., prostate cancer), or to treat unresectable tumours, recurring tumours, or residual disease. It is typically placed in the body by means of a remote-afterloading applicator using ultrasonic or fluoroscopic guidance.
GUDID devices
40
Last updated
2022-11-01 08:19:39

Related Product Codes

CodeDeviceSpecialtyClassDevices
KXKSource, Brachytherapy, RadionuclideRadiology238
IWJSystem, Applicator, Radionuclide, ManualRadiology11
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
10801741078061QuickLink™ Cartridge 5.5mm Standard SourceLink™Bard Brachytherapy, Inc.70301QC52015-10-05
10801741078078QuickLink™ Cartridge 5.5mm Standard SourceLink™Bard Brachytherapy, Inc.70301QC202015-10-05
10801741078085QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™Bard Brachytherapy, Inc.70302QC52015-10-05
10801741078092QuickLink™ Cartridge 0.5mm Seed-to-Seed SourceLink™Bard Brachytherapy, Inc.70302QC102015-10-05
10801741078139SourceLink™ 5.5mm Standard SourceLink™Bard Brachytherapy, Inc.70301202015-10-05
10801741078146SourceLink™ 0.5mm Seed-to-Seed SourceLink™Bard Brachytherapy, Inc.70302052015-10-05
10801741078153SourceLink™ 5.0mm Extension SourceLink™Bard Brachytherapy, Inc.70303102015-10-05
00801741184123SourceLink 5.5mm SpacerBard Brachytherapy, Inc.70304502020-08-06
00801741184130SourceLink 5.0mm SpacerBard Brachytherapy, Inc.70305502020-08-06
00841365106958Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.10174-7-122015-09-22
00841365107603Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.10175-42015-09-22
00841365112522Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.10113-82015-09-22
00841365112867Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.10175-112015-10-30
00841365113567Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.10179-52016-03-17
08717213018679selectSpacerNucletron B.V.130010P01-012017-05-25
00863593000204Sirius MRI MarkerC4 IMAGING, LLCC-01-99-00142016-02-19
00863593000211Sirius MRI MarkerC4 IMAGING, LLCF-01-01-00012016-06-21
00863593000228Sirius MRI Marker NSC4 IMAGING, LLCF-01-01-00112017-09-15
00812444024432SPACERRIVERPOINT MEDICAL, LLCIAS 910.5.0-502015-11-17
00812444024456SPACERRIVERPOINT MEDICAL, LLCIAS 910-5.5-502015-11-17
00812444026696RP SPACERRIVERPOINT MEDICAL, LLCRPS-910-5.5-1502017-06-09
00812444027921RP SpacerRIVERPOINT MEDICAL, LLCRPS-910-5.5-502018-02-15
00813787021348TheragenicsTHERAGENICS CORPORATIONPSS-910-55-502017-11-06
00813787021355TheragenicsTHERAGENICS CORPORATIONPSS-910-55-202017-11-06
00813787021362TheragenicsTHERAGENICS CORPORATIONPSS-910-50-502017-11-06
00813787021652TheragenicsTHERAGENICS CORPORATIONPSS-910-55-150NS2018-02-08
00813787021669TheragenicsTHERAGENICS CORPORATIONPSS-910-50-50NS2018-02-08
00815165020400Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub NeedleEckert & Ziegler Bebig, Inc.PSS1820SLS Round Hub Needle2015-10-27
00801741078316Bard® BrachySource® I-125 Loose Seed with SourceLink™ PackBard Brachytherapy, Inc.1251LINKL2015-10-05
00801741078323Bard® BrachySource® I-125 Loose Seed with SourceLink™ PackBard Brachytherapy, Inc.1251LNKLS2015-10-05
00801741078347Bard® BrachySource® I-125 Implant Seeds In ReadyLink™Bard Brachytherapy, Inc.STM1251RL2015-10-05
00801741078354Bard® QuickLink™ Cartridges with BrachySource® I-125 SeedsBard Brachytherapy, Inc.1251QCS2015-10-05
00801741078439Model 200 TheraSeed® Palladium-103 in CartridgesBard Brachytherapy, Inc.TS200CSF2015-10-05
00801741078446Model 200 TheraSeed® Palladium-103 Device in CartridgesBard Brachytherapy, Inc.200CNF2015-10-05
00801741078507Model 200 TheraSeed® Palladium-103 Loose Seed with SourceLink™ PackBard Brachytherapy, Inc.200LINKLS2015-10-05
00801741078545Bard® QuickLink™ Cartridges with Model 200 TheraSeed® Palladium-103Bard Brachytherapy, Inc.200QLL2015-10-05
00801741078552Bard® QuickLink™ Cartridges with Model 200 TheraSeed® Palladium-103Bard Brachytherapy, Inc.200QCL2015-10-05
00801741086786Model 200 TheraSeed® Palladium-103 in Bard® Preloaded NeedlesBard Brachytherapy, Inc.200N2015-10-05
00801741098604Bard® BrachySource® I-125 Implant Seed Preloaded in NeedlesBard Brachytherapy, Inc.1251PAP2015-10-05
00801741098666Model 200 TheraSeed® Palladium-103 in Bard® Preloaded NeedlesBard Brachytherapy, Inc.200PAPF2015-10-05