Spes Medica Pudendal Electrode

GUDID 08054655012897

SPES MEDICA SRL

Urodynamic measurement system
Primary Device ID08054655012897
NIH Device Record Keyeaa9c68e-acce-41fc-b92c-a66011f69c77
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpes Medica Pudendal Electrode
Version Model NumberPUD0001
Company DUNS514029771
Company NameSPES MEDICA SRL
Device Count10
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108054655012897 [Unit of Use]
GS118054655012894 [Primary]

FDA Product Code

FAPCystometric Gas (Carbon-Dioxide) On Hydraulic Device

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-19
Device Publish Date2020-03-11

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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