FDA.reportPublic FDA data

Intrauterine imaging medium catheter

Definition
A flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.
GUDID devices
127
Last updated
2026-08-03 17:33:56

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860011716853Monarch Medical ProductsBioteque Taiwan Ltd.MM1150A2026-07-24
04719894436456LTL MedicalBioteque Taiwan Ltd.BA05F2026-07-24
04719894432779BiotequeBioteque Taiwan Ltd.UIC5FAX2024-04-08
04719894432571BiotequeBioteque Taiwan Ltd.BA05F2024-04-08
04719894432588BiotequeBioteque Taiwan Ltd.BA07F2024-04-08
04719894432595BiotequeBioteque Taiwan Ltd.BA051F2024-04-08
04719894432601BiotequeBioteque Taiwan Ltd.BA071F2024-04-08
04719894432618BiotequeBioteque Taiwan Ltd.BA05F-ST2024-04-08
04719894432625BiotequeBioteque Taiwan Ltd.BA0012024-04-08
04719894432755BiotequeBioteque Taiwan Ltd.UIC5F2024-04-08
04719894432762BiotequeBioteque Taiwan Ltd.UIC5FA2024-04-08
00690521013735Batrik H/S Catheter TM 5FBatrik Medical Manufacturing Inc51-50052018-06-05
00690521013742Batrik H/S Catheter TM 7FBatrik Medical Manufacturing Inc51-50072018-06-05
00827002171473CookCOOK INCORPORATEDG171472016-09-24
00827002171497GoldsteinCOOK INCORPORATEDG171492016-09-24
00827002174719CookCOOK INCORPORATEDG174712016-09-24
00827002174726CookCOOK INCORPORATEDG174722016-09-24
00827002178700CookCOOK INCORPORATEDG178702016-09-24
00827002186644GoldsteinCOOK INCORPORATEDG186642016-09-24
00827002186651GoldsteinCOOK INCORPORATEDG186652016-09-24
00827002190122GoldsteinCOOK INCORPORATEDG190122016-09-24
00827002248137uVueCOOK INCORPORATEDG248132016-09-24
00827002461901GoldsteinCOOK INCORPORATEDG461902016-09-24
00852073002043NAC R I5F HS Catheter2016-10-03
00852073002050NAC R I7F HS Catheter2016-10-03
00852073002067NAC R I5F Shapeable HS Catheter2016-10-03
00852073002074NAC R I7F Shapeable HS Catheter2016-10-03
00852073002203MIller Advance CatheterC R I5F HS Catheter2016-10-10
00852073002210MIller Advance CatheterC R I5F HS Catheter2016-10-11
00852073002227MIller Advance CatheterC R I5F HS Catheter2016-10-11
00852073002340NAC R IHS Catheter w/Depth Marks, 5F2016-09-30
00852073002357NAC R IHS Catheter w/Depth Marks, 7F2016-09-30
00852073002821NAC R ITwo-Tap HS Catheter, 7F2016-09-30
00852073002838NAC R ITwo-Tap Shapeable HS Catheter, 5F2016-09-30
00852073002845NAC R ITwo-Tap Shapeable HS Catheter, 7F2016-09-30
00852073002852NAC R I5F Shapeable HS Catheter2016-09-26
00852073002890NAC R ISteen HS Catheter, 7F2016-09-30
00886333001163Hysterosalpingography (HSG) CatheterARGON MEDICAL DEVICES, INC.6600050402017-05-16
00886333001170Hysterosalpingography (HSG) CatheterARGON MEDICAL DEVICES, INC.6600070402017-05-16
00886333005734HSG Procedure TrayARGON MEDICAL DEVICES, INC.6600070002017-05-16
00886333005741HSG Procedure TrayARGON MEDICAL DEVICES, INC.6600050002017-05-16
04953170049422DISPOSABLE CANNULAOLYMPUS MEDICAL SYSTEMS CORP.PR-19A2018-09-21
05055270900340RocketROCKET MEDICAL PLCR574902017-01-16
05055270900357RocketROCKET MEDICAL PLCR574912017-01-16
05055270913715RocketROCKET MEDICAL PLCR574222016-09-02
05055270913722RocketROCKET MEDICAL PLCR57422-00-ST2016-09-02
05055270913739RocketROCKET MEDICAL PLCR574242016-09-02
05055270913746RocketROCKET MEDICAL PLCR57424-00-ST2016-09-02
05055270913845RocketROCKET MEDICAL PLCR574932017-01-16
05055270966148RocketROCKET MEDICAL PLCR57422-VIP2023-10-31
05055270973511RocketROCKET MEDICAL PLCR57424-00-ST2016-09-22
05055270974440RocketROCKET MEDICAL PLCR57424-VIP2023-10-31
05055270981370RocketROCKET MEDICAL PLCR57430-CONE2023-10-24
H671MIS50P0TVUS/HSG-CathUTAH MEDICAL PRODUCTS, INC.Peel-Away Introducer2016-09-23
H671MIS50ST0TVUS/HSG-CathUTAH MEDICAL PRODUCTS, INC.Integrated Stylet2016-09-23
04719894432632Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.BA05F2024-04-08
04719894432649Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.BA07F2024-04-08
04719894432656Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.BA051F2024-04-08
04719894432663Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.BA071F2024-04-08
04719894432670Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.BA05F-ST2024-04-08
04719894432687Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.BA0012024-04-08
04719894432786Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.UIC5F2024-04-08
04719894432793Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.UIC5FA2024-04-08
04719894432809Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.UIC5FAX2024-04-08
05055270966155RocketROCKET MEDICAL PLCR57422-VIP2023-10-31
05055270974457RocketROCKET MEDICAL PLCR57424-VIP2023-10-31
05055270981387RocketROCKET MEDICAL PLCR57430-CONE2023-10-24
00812261016689HYSTERO CATHALLWIN MEDICAL DEVICES, INC.HYSTERO CATH Hysterosalpingography Catheter Closed2023-07-28
00860010540909Rejoni Intrauterine CatheterRejoni, Inc.CA-20152023-07-14
00827002162648CookCOOK INCORPORATEDG162642020-10-02
00827002165755SholkoffCOOK INCORPORATEDG165752016-09-24
00827002166332TenacathCOOK INCORPORATEDG166332016-09-24
00827002169098TenacathCOOK INCORPORATEDG169092016-09-24
10827002171470CookCOOK INCORPORATEDG171472016-09-24
00827002173590CookCOOK INCORPORATEDG173592016-09-24
00827002175907CookCOOK INCORPORATEDG175902016-09-24
10827002174716CookCOOK INCORPORATEDG174712016-09-24
10827002174723CookCOOK INCORPORATEDG174722016-09-24
00827002178687CookCOOK INCORPORATEDG178682016-09-24
10827002178707CookCOOK INCORPORATEDG178702016-09-24