Spes Medica Subdermal Needle Electrodes

GUDID 18054655025092

SPES MEDICA SRL

Electromyographic needle electrode, single-use
Primary Device ID18054655025092
NIH Device Record Key67bce8c9-1f94-4a85-82d7-6c95f1e1702a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpes Medica Subdermal Needle Electrodes
Version Model NumberMNCS0615US
Company DUNS514029771
Company NameSPES MEDICA SRL
Device Count24
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108054655025095 [Unit of Use]
GS118054655025092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZElectrode, Needle

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-05
Device Publish Date2020-01-28

On-Brand Devices [Spes Medica Subdermal Needle Electrodes]

18054655024750MN4008D25A/S
18054655024743MN4008D10A/S
18054655024736MN4018D20A/S
18054655024729MN4013D20B/S
18054655024682MN4008D25B
18054655024675MN4008D25S
18054655024668MN4008D15B
18054655024651MN4008D15S
18054655024644MN4008D10B
18054655024637MN4008D10S
18054655024620MN4022D25S
18054655024613MN4022D15S
18054655023340MN4018D25S
18054655023333MN4018D15S
18054655022381MN4018D15A/S
18054655022275MN4022D10S
18054655022077MN4018D10A/S
18054655021926MN4018D10S
18054655018841MN4013D15S
18054655011910MN4013D25S
18054655011873MN4013D25B
18054655011804MN4013D20A/S
18054655011743MN4013D15B/S
18054655011736MN4013D15B
18054655011729MN4013D15A/S
18054655011552MN4013D10S
18054655011538MN4013D10B/S
18054655011521MN4013D10B
18054655011514MN4013D10A/S
18054655011378MN4008D15A/S
18054655024828MNCS0615DT5
18054655024811TT05MN4018D/25
18054655024804TT03MN4018D/25
18054655024712MN4013CD20S
18054655024705MN4013CD15S
18054655024699MN4013CD10S
18054655023814MNCS0610DTS
18054655023401TT10MN4018D/15
18054655023395TT10MN4018D/25
18054655023081TT05MN4018D/15
18054655023074TT03MN4018D/15
18054655018780MNCS0615DT6
18054655012542MNCS0625DTS
18054655012498MNCS0615DTS
18054655011958MN4013HD25S
18054655011934MN4013HD15S
18054655011927MN4013HD10S
18054655025108MNCS0625US
18054655025092MNCS0615US
18054655025085MNCS0610US

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