PG479/50W/US

GUDID 08054242447828

PG479/50W/US are round-shaped disposable adhesive electrodes with solid conductive gel. High material flexibility permits to apply electrodes very easily on treating areas. Solid gel maintains unchanged the electrode adhesion and conductivity, during procedure. The electrodes Ø 50 mm are equipped with a 10 cm long cable, with 2mm socket. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient’s skin. The electrodes are non-sterile and for single patient use only. Latex free.

FIAB SPA

Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use
Primary Device ID08054242447828
NIH Device Record Keyf02d2c5d-61e5-4146-ae42-9083d10acc55
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPG479/50W/US
Catalog NumberPG479/50W/US
Company DUNS439770017
Company NameFIAB SPA
Device Count4
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it
Phone+39 0558497943
Emailquality@fiab.it

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 35 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108054242447828 [Primary]
GS178054242447827 [Unit of Use]

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 Number2
Public Version Date2021-02-19
Device Publish Date2020-06-12

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