Recording and stimulating for Central Nervous System electrodes

GUDID 18054655028222

SPES MEDICA SRL

Cortical electrode
Primary Device ID18054655028222
NIH Device Record Key6a787bfd-136b-41c7-909f-ddb1141764e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRecording and stimulating for Central Nervous System electrodes
Version Model NumberIEP0008
Company DUNS514029771
Company NameSPES MEDICA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS118054655028222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GYCElectrode, Cortical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-07
Device Publish Date2022-11-29

On-Brand Devices [Recording and stimulating for Central Nervous System electrodes]

18054655028239IEP0006
18054655028222IEP0008
18054655026815IEP0007

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