FDA.reportPublic FDA data

Tech Dots - Adhesive and Conductive Gel

Primary DI
18054655025627
Brand
Tech Dots - Adhesive and Conductive Gel
Company
SPES MEDICA SPA
Model
DOT024-25
Published
2019-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GYBMedia, Electroconductive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GYBMedia, ElectroconductiveNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190050000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190050000Tech Dots - Adhesive and conductive gelSpes Medica Srl2019-07-19GYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054655025627PrimaryGS10
08054655026030Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805465502562718054655025627
08054655026030080546550260308054655026030

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514029771
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18054655007630Disposable Adhesive Surface ElectrodesDENIS020252025-11-21
18054655007623Disposable Adhesive Surface ElectrodesDENIS020252016-06-17
18054655008415Disposable EMG needle electrodesDSFN3804537072025-03-03
18054655023357Disposable EMG needle electrodesDSFN3804525062025-03-03
08054655008418Disposable EMG needle electrodesDSFN3804537072025-03-03
08054655023350Disposable EMG needle electrodesDSFN3804525062025-03-03
08054655036657MR Conditional Disposable EEG Cup ElectrodeDCPEX-29B2025-02-24
18054655025986Urethral Catheter ElectrodeUE0032025-02-24
18054655026006Urethral Catheter ElectrodeUE0052025-02-24
18054655030386Urethral Catheter ElectrodeUE0172025-02-24
18054655028062Tech Tape - Adhesive TapeTAPE024-252019-10-17
18054655010876Spes Medica Subdermal Needle ElectrodesMN2013D10S2020-08-11
18054655012894Spes Medica Pudendal ElectrodePUD00012020-03-11
18054655020790Connection cableSBM1AE0012024-05-13
18054655021704Connection cableSBM1AE0022024-05-13
18054655021711Connection cableSBM1AE0032024-05-13
18054655023661AC Cream - Conductive PasteACCREAM250V-32021-12-22
18054655030034Connection cableSBM1AE0042024-05-13
18054655030720IOM Stimulator ProbesSI1B0185S2526D2021-02-04
18054655031031Disposable Adhesive Surface ElectrodesTEON2F50902021-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09342451003416Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003423Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003430Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
09342451003447Compumedics Quik-GelCOMPUMEDICS LIMITEDGYB2026-03-12
00197998355363Solventum™Solventum US LLCGYB2026-02-15
00197998355400Solventum™Solventum US LLCGYB2026-02-15
00197998355370Solventum™Solventum US LLCGYB2026-02-15
00197998355417Solventum™Solventum US LLCGYB2026-02-15
06973602730795FyneLookTOP-RANK HEALTH CARE CO., LTD.GYB2025-10-23
06974667824986JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06974667824993JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06974667825006JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667824983JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667824990JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
16974667825003JMOONShenzhen Ulike Smart Electronics Co., Ltd.GYB2025-06-07
06973602730627MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-04-23
06973602730610MedvatTOP-RANK HEALTH CARE CO., LTD.GYB2025-03-18
00850024089235MedvatMyt Enterprises LLCGYB2025-02-19
00840295408224TherabodyTherabody, Inc.GYB2025-01-26
B1870800TheraMistNEUROTRON MEDICAL, INC.GYB2024-12-04
06971292004011AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-29
16971292006739AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
16971292006746AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
26971292006736AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
26971292006743AUVONShenzhen Yuwen E-Commerce Co., Ltd.GYB2024-08-13
04260280180335AxionAxion USA LLCGYB2024-03-18
04262356159993EEG-acpCNSAC Medshop GmbHGYB2024-01-22
B311PEHTNPDS20PURE ENRICHMENTBEAR DOWN CONSULTINGGYB2023-12-14
B311PEHTNPDS50PURE ENRICHMENTBEAR DOWN CONSULTINGGYB2023-12-14
00850021097561Nu Skin RenuSpa iO PackageNSE PRODUCTS, INC.GYB2023-11-27