FDA.reportPublic FDA data

Topical coupling gel, non-sterile

Definition
A non-sterile medium designed to be applied to a patient's unbroken skin surface to provide a coupling between an analytical device (e.g., ultrasound transducer, optical glucose monitoring system) and the patient, allowing for the emission and reception of signals (e.g., ultrasound, light) that pass through the skin during an examination. It is in the form of a non-sticky, fluid-like gel that may also assists the operator's ability to move the analytical device smoothly over the skin to better analyse the site of interest. It may be used by a healthcare professional or layperson. After application, this device cannot be reused.
GUDID devices
38
Last updated
2022-06-10 15:35:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07350025911205VitrolifeNEXT MEDICAL PRODUCTS, LLC142132020-10-05
08057733230084ECO SUPERGELCERACARTA SPAULTRASOUND GEL2018-12-18
08057733230107ECO SUPERGELCERACARTA SPAULTRASOUND GEL2018-12-18
08057733230145ECO SUPERGEL CLEARCERACARTA SPAULTRASOUND GEL CLEAR2018-12-18
08057733230176ECO SUPERGEL CLEARCERACARTA SPAULTRASOUND GEL CLEAR 260 G2018-12-18
40080196166252MedlineMEDLINE INDUSTRIES, INC.MDS0920052016-10-14
40080196166290MedlineMEDLINE INDUSTRIES, INC.MDS0920102016-09-27
10612479188393McKessonMCKESSON MEDICAL-SURGICAL INC.49612016-12-09
10612479188416McKessonMCKESSON MEDICAL-SURGICAL INC.49622016-12-09
10612479188430McKessonMCKESSON MEDICAL-SURGICAL INC.49632016-12-09
10612479188454McKessonMCKESSON MEDICAL-SURGICAL INC.49642016-12-09
10660584000222DynaGel™ Ultrasound Gel, 5 Liters, BlueDynatronics Corporation5LTRGEL-B2016-11-18
10660584000895DynaGel™ Ultrasound Gel, sampleDynatronics Corporation7B02172016-11-18
10660584000901DynaGel™ Ultrasound Gel, 5 Liters, BlueDynatronics Corporation5LTRGEL-B2018-10-18
10660584000925Dynatron® Lotion, 1 GallonDynatronics CorporationDL12016-11-18
20660584000915DynaGel™ Ultrasound Gel, 5 Liters, ClearDynatronics Corporation5LTRGEL2016-11-18
20815112020563E-Z-GEL UltraSound GelBRACCO DIAGNOSTICS INC6010042016-09-23
30815112020539E-Z-GEL UltraSound GelBRACCO DIAGNOSTICS INC6010012016-09-23
30815112020546E-Z-SCAN Low Viscosity UltraSound GelBRACCO DIAGNOSTICS INC6010022016-09-23
30815112020553E-Z-SCAN Low Viscosity UltraSound GelBRACCO DIAGNOSTICS INC6010032016-09-23
20842418102037SheathesGelSHEATHING TECHNOLOGIES, INC.G2012016-09-22
20842418102570Sheathes Pre-GelledSHEATHING TECHNOLOGIES, INC.470902018-07-24
20842418102587Sheathes Pre-GelledSHEATHING TECHNOLOGIES, INC.47280-PT2018-07-24
20842418104048Sheathes3D Pre-GelledSHEATHING TECHNOLOGIES, INC.77380-PT2018-08-09
20842418104260Sheathes Pre-GelledSHEATHING TECHNOLOGIES, INC.279802019-08-29
10856724004179Clear ImageNEXT MEDICAL PRODUCTS, LLC02-1052016-10-24
10856724004186Clear ImageNEXT MEDICAL PRODUCTS, LLC05-1052016-10-24
20885380066020CARDINAL HEALTHCardinal Health 200, LLCUSG-60TB2016-08-15
20885380066037CARDINAL HEALTHCardinal Health 200, LLCUSG-250BT2016-08-15
10885632133374MedichoiceOWENS & MINOR DISTRIBUTION, INC.200405042016-08-26
10885914075927METRONPerformance Health Supply, LLC5687822017-01-31
10885914077440PerformaPerformance Health Supply, LLC0817107552017-10-12
50885632133365MedichoiceOWENS & MINOR DISTRIBUTION, INC.100802122016-08-26
50885632134348MedichoiceOWENS & MINOR DISTRIBUTION, INC.M5005L42016-08-29
50885632134355MedichoiceOWENS & MINOR DISTRIBUTION, INC.M5008122016-08-29
M220P3010083Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.P3010082017-02-13
M220P3011053Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.P3011052017-02-13
M220P3011153Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.P3011152017-02-13