AccessGUDID - DEVICE: BioWave Noninvasive Electrodes (00859911006140)

GUDID

Device Identifier (DI) Information

Brand Name: BioWave Noninvasive Electrodes
Version or Model: GOPADS_1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOWAVE CORPORATION

Primary DI Number: 00859911006140
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 005759084 *Terms of Use

Device Description: BioWave Noninvasive Electrodes - 3 pack (3 pairs) - for use with BioWaveGO High Frequency Neurostimulators

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):	No
Over the Counter (OTC):	Yes
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?
65318	Transcutaneous electrical stimulation electrode, reusable	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180943	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 580592f0-d3f9-4a46-916e-c3768334177d
Public Version Date: August 15, 2023
Public Version Number: 1
DI Record Publish Date: August 07, 2023