FDA.reportPublic FDA data

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
220
Last updated
2022-05-31 02:58:52

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190446227472DONJOY PERFORMANCEDJO, LLCDP163CT052022-05-21
00190446227489DONJOY PERFORMANCEDJO, LLCDP163CT062022-05-21
00190446227496DONJOY PERFORMANCEDJO, LLCDP163CT072022-05-21
10810041988567ViveProVIVE HEALTH LLCRHB1088SET2021-12-09
20842418104178Sheathes3D Pre-GelledSHEATHING TECHNOLOGIES, INC.877802021-09-30
00628108100356SonicshieldNational Therapy Products IncSONX201X2021-08-17
00628108100363SonicshieldNational Therapy Products IncSONX020X2021-08-17
00628108100370SonicshieldNational Therapy Products IncSONX500X2021-08-17
04260153472031Swiss DolorClastE.M.S. Electro Medical Systems S.A.DV-0332021-06-02
10035135013059MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.CTR0013052021-02-24
05060813630349RED Medical Supplies Red Medical Supplies Ltd250UG-BMU2021-02-05
05060813630356RED Medical Supplies Red Medical Supplies Ltd250UG-BMU-BL2021-02-05
05060813630363RED Medical Supplies Red Medical Supplies Ltd5LUG-BMU2021-02-05
05060813630370RED Medical Supplies Red Medical Supplies Ltd250UG-CMV2021-02-05
05060813630387RED Medical Supplies Red Medical Supplies Ltd250UG-CMV-BL2021-02-05
05060813630394RED Medical Supplies Red Medical Supplies Ltd5LUG-CMV2021-02-05
05060813630400RED Medical Supplies Red Medical Supplies Ltd250UG-GLV2021-02-05
05060813630417RED Medical Supplies Red Medical Supplies Ltd250UG-GLV-BL2021-02-05
05060813630424RED Medical Supplies Red Medical Supplies Ltd5LUG-GLV2021-02-05
00850024089211MedvatMyt Enterprises LLC200C2021-01-21
00850024089549MedvatMyt Enterprises LLC5L4C2021-01-21
00850024089822MedvatMyt Enterprises LLC852C2021-01-21
00628055650751EcoGel 200 ClearEco-Med Pharmaceutical Inc40JBC-HV-242020-12-18
50885380066014CARDINAL HEALTHCardinal Health 200, LLCUSG20-NS2016-08-15
50885380066045CARDINAL HEALTHCardinal Health 200, LLCUSG-5L2016-08-15
07613353170264Swiss DolorClastE.M.S. Electro Medical Systems S.A.DV-0332020-06-03
00888937017069WALLACH® Summit Doppler™ Ultrasound Gel 60 gramsCoopersurgical, Inc.G1502017-01-18
00888937017076WALLACH® Summit Doppler™ Ultrasound Gel 250 gramsCoopersurgical, Inc.G1552017-01-18
10851809002132HR Ultrasound JellyHR PHARMACEUTICALS INC.2132016-09-24
10810041981827VIVEVIVE HEALTH LLCRHB10882020-04-07
M3684001GF2GRAFCOGF HEALTH PRODUCTS, INC.4001GF2020-04-01
M3684002GF2GRAFCOGF HEALTH PRODUCTS, INC.4002GF2020-04-01
00628055650492EcoGel 200 Eco-Med Pharmaceutical Inc40JSP2020-01-15
00628055650553EcoGel 200 Eco-Med Pharmaceutical Inc40JSPC-HV2020-01-15
00628055650584EcoGel 200 Eco-Med Pharmaceutical Inc40JSP-HV2020-01-15
00628055650683EcoGel 200 Eco-Med Pharmaceutical Inc40JSPC2020-01-15
00628055650706EcoGel 200 Eco-Med Pharmaceutical Inc40JB-HV2020-01-15
00628055650713EcoGel 200 Eco-Med Pharmaceutical Inc40JS-HV2020-01-15
00628055650973EcoGel 200Eco-Med Pharmaceutical Inc40JSC-HV2020-01-15
20842418104277Sheathes3D Pre-GelledSHEATHING TECHNOLOGIES, INC.875802019-09-20
00869209000224dBsonx™DBMEDX INC.PD-040-00142016-08-04
00628108100271WavelengthNational Therapy Products IncNTPC025X2019-06-04
10628108100254WavelengthNational Therapy Products IncNTPA102X2019-06-04
10628108100261WavelengthNational Therapy Products IncNTPB100X2019-06-04
10628108100285WavelengthNational Therapy Products IncNTPC204X2019-06-04
10628108100308WavelengthNational Therapy Products IncNTPD373C2019-06-04
10628108100315WavelengthNational Therapy Products IncNTPF100X2019-06-04
10628108100322WavelengthNational Therapy Products IncNTPF101X2019-06-04
10628108100339Wavelength National Therapy Products IncNTPF301X2019-06-04
10628108100346WavelengthNational Therapy Products IncNTPF202T2019-06-04
20842418104192Sheathes Pre-GelledSHEATHING TECHNOLOGIES, INC.27085-P2019-04-30
07350025911212VitrolifeNEXT MEDICAL PRODUCTS, LLC142142020-10-05
20842418104161SheathesSHEATHING TECHNOLOGIES, INC.9-473802019-04-05
17350025911660Ultrasound Transmission GelVitrolife Sweden AB142032016-09-13
20884527017291KendallCardinal Health, Inc.40612016-09-24
30856724004012Clear ImageNEXT MEDICAL PRODUCTS, LLC02-9122016-10-24
30856724004029Clear ImageNEXT MEDICAL PRODUCTS, LLC02-4052016-10-24
30856724004036Clear ImageNEXT MEDICAL PRODUCTS, LLC05-9122016-10-24
30856724004043Clear ImageNEXT MEDICAL PRODUCTS, LLC05-4052016-10-24
30856724004067Clear Image SinglesNEXT MEDICAL PRODUCTS, LLC02-400B-0302016-10-24
30856724004074Clear Image SinglesNEXT MEDICAL PRODUCTS, LLC02-400-0302016-10-24
30856724004098Clear Image SinglesNEXT MEDICAL PRODUCTS, LLC02-400B-0152016-10-24
30856724004104Clear Image SinglesNEXT MEDICAL PRODUCTS, LLC02-400-0152016-10-24
30856724004128Clear Image Singles LiteNEXT MEDICAL PRODUCTS, LLC06-400B-0302016-10-24
30856724004135Clear Image Singles LiteNEXT MEDICAL PRODUCTS, LLC06-400-0302016-10-24
30856724004142LithoClearNEXT MEDICAL PRODUCTS, LLC11-6012016-10-24
30856724004159LithoClearNEXT MEDICAL PRODUCTS, LLC11-4052016-10-24
30856724004197Clear ImageNEXT MEDICAL PRODUCTS, LLC02-8122016-10-24
30856724004203Clear ImageNEXT MEDICAL PRODUCTS, LLC05-8122016-10-24
30856724004326Clear Image SinglesNEXT MEDICAL PRODUCTS, LLC02-050-0302016-10-24
30856724004333ClearWaveNEXT MEDICAL PRODUCTS, LLC170002016-10-24
30856724004340ClearWaveNEXT MEDICAL PRODUCTS, LLC179032016-10-24
30856724004357Clear Image Singles LiteNEXT MEDICAL PRODUCTS, LLC06-050-0302016-10-24
20884527017284KendallCardinal Health, Inc.40602016-09-24
50885632133389MedichoiceOWENS & MINOR DISTRIBUTION, INC.304004002016-08-29
10849027000146HCSDYAD MEDICAL SOURCING, LLCHCS50062017-01-17
10849027000153HCSDYAD MEDICAL SOURCING, LLCHCS50072017-01-17
10849027002584HCSDYAD MEDICAL SOURCING, LLCHCS5006C2017-01-17
00850958007527GelShotDrive Devilbiss HealthcareGS9072016-11-23
00850958007534GelShotDrive Devilbiss HealthcareGS9012016-11-23