Tech Dots - Adhesive and Conductive Gel

GUDID 18054655025627

SPES MEDICA SRL

Electrode conductive medium
Primary Device ID18054655025627
NIH Device Record Key61ae5366-bff1-46ed-9fcb-9d7eb0fc98e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameTech Dots - Adhesive and Conductive Gel
Version Model NumberDOT024-25
Company DUNS514029771
Company NameSPES MEDICA SRL
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108054655026030 [Unit of Use]
GS118054655025627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GYBMedia, Electroconductive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-24
Device Publish Date2019-09-16

Devices Manufactured by SPES MEDICA SRL

08054655020793 - Connection cable2024-05-21
08054655021707 - Connection cable2024-05-21
08054655021714 - Connection cable2024-05-21
08054655030037 - Connection cable2024-05-21
18054655026815 - Recording and stimulating for Central Nervous System electrodes2022-12-07
18054655028222 - Recording and stimulating for Central Nervous System electrodes2022-12-07
18054655028239 - Recording and stimulating for Central Nervous System electrodes2022-12-07
18054655000402 - Connection cable2021-12-30

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