FDA.reportPublic FDA data

Breast brachytherapy system applicator, remote-afterloading

Definition
A sterile, remote-afterloading brachytherapy applicator specifically designed for use in radiation therapy treatments of the breast. It is typically designed for temporary implantation within the breast and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources. Included are various types of applicators such as hollow needles, tubes, or catheters, and their associated components. This is a single-use device.
GUDID devices
24
Last updated
2024-10-24 16:04:05

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
15420045506411ATECHologic, Inc.MME-003452019-07-30
15420045506428ATECHologic, Inc.MME-017822019-07-30
15420045509955MammositeHologic, Inc.9190042019-07-30
15420045509979MammositeHologic, Inc.WINDSTONE2019-07-30
00841365118593Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.70012020-12-29
15420045505001Mammosite Variable 4-5 cm Applicator TrayHologic, Inc.919007-012016-08-04
15420045505018Mammosite Cavity Evaluation Device Kit (CED)Hologic, Inc.9260002016-08-04
15420045505025Mammosite Multi-lumen Applicator TrayHologic, Inc.ML23452016-08-04
154200455051484-5 CM CONTURA MLB CATHETER w/TRI INTRODUCERHologic, Inc.B012452017-02-09
154200455051554-5 CM CONTURA MLB CATHETER w/TRI INTRODUCERHologic, Inc.B012562017-02-09
154200455051624.0-5.0 CM CONTURA® MLB CATHETER w/OUT INTRODUCERHologic, Inc.B013452017-02-09
154200455051794.5-6.0 CM CONTURA® MLB CATHETER w/OUT INTRODUCERHologic, Inc.B013562017-02-09
154200455051864-5 CM CONTURA MLB CATHETER w/ BLUNT INTRODUCERHologic, Inc.B032452017-02-09
154200455051934-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCERHologic, Inc.B112452017-02-09
154200455052094.5-6.0 CM CONTURAFLEX MLB CATHETER w/ TRI INTROHologic, Inc.B112562017-02-09
154200455052164-5 CM CONTURAFLEX MLB CATHETER w/BLUNT TIP INTROHologic, Inc.B132452017-02-09
154200455052234.5-6 CM CONTURAFLEX CATHETER w/BLUNT TIP INTROHologic, Inc.B132562017-02-09
154200455052304.0-5.0 CM CT LUMEN MARKER SETHologic, Inc.B900032017-02-09
154200455052474.5-6.0 CM CT LUMEN MARKER SETHologic, Inc.B900042017-02-09
15420045505254CONTURA® INTRODUCER & SPLIT SHEATH, BLUNT TIPHologic, Inc.B900092017-02-09
154200455052613.5-5.0 CM CONTURA CMC w/ TRICONCAVE INTRODUCERHologic, Inc.B900122017-02-09
25420045505039Neucletron HDR Afterloader Connectors wObturatorsHologic, Inc.8190012016-08-04
25420045505046Varian HDR Afterloader Connectors with ObturatorsHologic, Inc.8190022016-08-04
25420045505053GammaMed HDR Afterloader Connectors wObturatorsHologic, Inc.8190032016-08-04