PG471/50W/US

GUDID 08054242447811

PG471/50W/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 50mm 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

• Primary Device ID: 08054242447811
• NIH Device Record Key: b48df8ff-3120-4bf4-ad3b-17e6b3b19f22
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: PG471/50W/US
• Catalog Number: PG471/50W/US
• Company DUNS: 439770017
• Company Name: FIAB SPA
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it
• Phone: +39 0558497943
• Email: quality@fiab.it

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08054242447811 [Primary]
GS1	78054242447810 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091163

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-02-19
• Device Publish Date: 2020-06-12

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