FDA.reportPublic FDA data

Manual brachytherapy source, permanent implant

Definition
A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.
GUDID devices
519
Last updated
2026-07-17 21:58:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05060116920253TheraSphere Administration SetBIOCOMPATIBLES UK LTD990226.SPE2014-09-24
05060116921373TheraSphere Y90 Glass Microspheres 3.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921380TheraSphere Y90 Glass Microspheres 3.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921397TheraSphere Y90 Glass Microspheres 4.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921403TheraSphere Y90 Glass Microspheres 4.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921410TheraSphere Y90 Glass Microspheres 5.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921427TheraSphere Y90 Glass Microspheres 5.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921434TheraSphere Y90 Glass Microspheres 6.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921441TheraSphere Y90 Glass Microspheres 6.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921458TheraSphere Y90 Glass Microspheres 7.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921465TheraSphere Y90 Glass Microspheres 7.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921472TheraSphere Y90 Glass Microspheres 8.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921489TheraSphere Y90 Glass Microspheres 8.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921496TheraSphere Y90 Glass Microspheres 9.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921502TheraSphere Y90 Glass Microspheres 9.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921519TheraSphere Y90 Glass Microspheres 10.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921526TheraSphere Y90 Glass Microspheres 10.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921533TheraSphere Y90 Glass Microspheres 11.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921540TheraSphere Y90 Glass Microspheres 11.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921557TheraSphere Y90 Glass Microspheres 12.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921564TheraSphere Y90 Glass Microspheres 12.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921571TheraSphere Y90 Glass Microspheres 13.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921588TheraSphere Y90 Glass Microspheres 13.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921595TheraSphere Y90 Glass Microspheres 14.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921601TheraSphere Y90 Glass Microspheres 14.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921618TheraSphere Y90 Glass Microspheres 15.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921625TheraSphere Y90 Glass Microspheres 15.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921632TheraSphere Y90 Glass Microspheres 16.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921649TheraSphere Y90 Glass Microspheres 16.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921656TheraSphere Y90 Glass Microspheres 17.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921663TheraSphere Y90 Glass Microspheres 17.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921670TheraSphere Y90 Glass Microspheres 18.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921687TheraSphere Y90 Glass Microspheres 18.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921694TheraSphere Y90 Glass Microspheres 19.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921700TheraSphere Y90 Glass Microspheres 19.5 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116921717TheraSphere Y90 Glass Microspheres 20.0 GBq (US Commercial)BIOCOMPATIBLES UK LTDOTT-SPE-FP-700 (990700.SPE)2020-06-19
05060116922073TheraSphere Administration Accessory Kit (US)BIOCOMPATIBLES UK LTDK125914-0012020-06-19
00850014612030SIR-Spheres Y-90 resin microspheresSirtex Medical Inc.SIR-Y0012024-07-15
00850014612146SIR-Spheres Y-90 resin microspheresSirtex Medical Inc.SIR-Y0022024-03-28
00850014612153SIR-Spheres Y-90 resin microspheresSirtex Medical Inc.SIR-Y0032026-05-28
M425SIRY0010SIR-Spheres microspheresSirtex Medical Inc.SIR-Y0012014-09-24
00810020083132Gold MarkerRIVERPOINT MEDICAL, LLCGM10332020-03-26
00810020083149Gold MarkerRIVERPOINT MEDICAL, LLCGM12332020-03-26
00812444026290Gold MakerRIVERPOINT MEDICAL, LLCGM10542018-07-11
00812444027976Gold MarkerRIVERPOINT MEDICAL, LLCGM08332018-07-11
00812444027990Gold MarkerRIVERPOINT MEDICAL, LLCGM12542018-07-11
00812444028829Gold MarkerRIVERPOINT MEDICAL, LLCGM10322018-10-03
00860000064507GammaTile™GT MEDICAL TECHNOLOGIES, INC.GT-0012018-09-01
00860000064545GammaTileGT MEDICAL TECHNOLOGIES, INC.GT-0012024-04-29
M936IIS4721IsoSphereISOAID, L.L.C.IIS4722026-05-12
M936ILVN0Advantage I-125®ISOAID, L.L.C.ILVN2016-02-04
M936ILVN9Advantage I-125®ISOAID, L.L.C.ILVN2016-02-04
M936ILVS0Advantage I-125®ISOAID, L.L.C.ILVS2016-02-04
M936ILVS9Advantage I-125®ISOAID, L.L.C.ILVS2016-02-04
M936PDIS4721IsoSphereISOAID, L.L.C.PdIS4722026-05-12
M936PLVN0Advantage Pd-103®ISOAID, L.L.C.PLVN2016-02-04
M936PLVN9Advantage Pd-103®ISOAID, L.L.C.PLVN2016-02-04
M936PLVS0Advantage Pd-103®ISOAID, L.L.C.PLVS2016-02-04
M936PLVS9Advantage Pd-103®ISOAID, L.L.C.PLVS2016-02-04
M936PMLS9Advantage Pd-103®ISOAID, L.L.C.PMLS2016-02-04
00191506025229TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US03002026-03-01
00191506025236TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US03502026-03-01
00191506025243TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US04002026-03-01
00191506025250TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US04502026-03-01
00191506025267TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US05002026-03-01
00191506025274TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US05502026-03-01
00191506025281TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US06002026-03-01
00191506025298TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US06502026-03-01
00191506025304TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US07002026-03-01
00191506025311TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US07502026-03-01
00191506025328TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US08002026-03-01
00191506025335TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US08502026-03-01
00191506025342TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US09002026-03-01
00191506025359TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US09502026-03-01
00191506025366TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US10002026-03-01
00191506025373TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US10502026-03-01
00191506025380TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US11002026-03-01
00191506025397TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US11502026-03-01
00191506025403TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US12002026-03-01
00191506025410TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139552US12502026-03-01