FDA.reportPublic FDA data

Manual-afterloading brachytherapy system source delivery procedure kit

Definition
A collection of sterile devices intended to dispense/collect hydraulic fluid used to deliver the radiation source train of a manual-afterloading brachytherapy system source transfer device to/from the delivery catheter/applicator. It consists of disposable devices such as syringes, fluid collection bags, adaptors/connectors. This is a single-use device.
GUDID devices
8
Last updated
2026-07-17 21:58:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05060116920635TheraSphere Administration SetBIOCOMPATIBLES UK LTDOTT-SPE-FP-0012018-11-01
00191506025571TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139553CEA02026-03-01
00191506025595TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139554BBR02026-03-01
M097PAP00350Procedure Accessory PackBEST VASCULAR, INC.PAP-00352015-09-10
M097PAP00351Procedure Accessory Pack, 3.5F Coronary System, 5-PackBEST VASCULAR, INC.PAP-00352016-06-22
00191506025588TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139553CEA02026-03-01
00191506025601TheraSphere™BOSTON SCIENTIFIC CORPORATIONM00139554BBR02026-03-01
05060116920659TheraSphere Administration SetBIOCOMPATIBLES UK LTDOTT-SPE-FP-0012018-11-01