Disposable Adhesive Surface Electrodes

GUDID 18054655005131

SPES MEDICA SRL

Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use
Primary Device ID18054655005131
NIH Device Record Key05aea91d-8def-431f-821d-1148f02ef526
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Adhesive Surface Electrodes
Version Model NumberCDER246026
Company DUNS514029771
Company NameSPES MEDICA SRL
Device Count120
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 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
GS108054655005134 [Unit of Use]
GS118054655005131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXYElectrode, Cutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-06-21

On-Brand Devices [Disposable Adhesive Surface Electrodes]

18054655025740DENIS15026A/S
18054655014911TEON2F50100
18054655014904TEON1S5090
18054655014898TEON1S5045
18054655014881TEON1S4090
18054655014874TEON1S3545
18054655014867TEON1F5090
18054655014850TEON1F5045
18054655014843TEON1F4090
18054655014836TEON1F3545
18054655014812TABSMP000025
18054655014805TABSM0000025
18054655007746DENIS25026
18054655007715DENIS15026
18054655007678DENIS10026
18054655007623DENIS02025
18054655007593DENIS01526
18054655007562DENIS01520
18054655007548DENIS01500
18054655007524DENIS00830
18054655007494DENIS00807
18054655007470DENIL25026
18054655007449DENIL15026
18054655007432DENIL10026
18054655007388DENIL01526
18054655007357DENIL00830
18054655007333DENIL00807
18054655007289DENIG15026
18054655005612CODE501526
18054655005605CODE501500
18054655005575CODE401526
18054655005568CODE401500
18054655005230CDES003545
18054655005179CDES000024
18054655005155CDER2490F4
18054655005148CDER249026
18054655005131CDER246026
18054655005070CDE0309026
18054655005063CDE0306026
18054655005056CDE0249026
18054655005049CDE02460F4
18054655005025CDE0246026
18054655027423DENIS25026A/S
08054655031041TEON2F100150F
08054655031034TEON2F5090

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