AccessGUDID - DEVICE: 2" square fabric electrode (00860019001616)

GUDID

Device Identifier (DI) Information

Brand Name: 2" square fabric electrode
Version or Model: SF5050WP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELITE MEDICAL SUPPLY OF NY

Primary DI Number: 00860019001616
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 608469891 *Terms of Use

Device Description: 2" square white non-woven fabric cutaneous hydrogel electrode, package contains 4 individual electrodes.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45208	Interferential electrical stimulation system electrode	A component of an interferential electrical stimulation system designed to conduct electrical currents from the system's pulse generator to specific areas of the body typically to treat pain. In interferential treatment it is typical to use two electrical conductors (electrodes) that are attached to the patient's skin at opposite corners of a square along which currents are delivered (e.g., 4000 and 41000 Hz) that interfere at its centre. This results in a beat frequency at the difference between the frequencies and this is used to treat muscle disorders or, at higher frequencies, to relieve pain. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 2 Inch
Length: 2 Inch

Device Record Status

Public Device Record Key: 19f5233b-7d55-4221-8487-ded8134e8c8c
Public Version Date: October 24, 2024
Public Version Number: 2
DI Record Publish Date: March 19, 2018