AccessGUDID - DEVICE: Three degrees (06976378040020)

GUDID

Device Identifier (DI) Information

Brand Name: Three degrees
Version or Model: Circular
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dong Guan Ou Kang Electronics CO.,LTD

Primary DI Number: 06976378040020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554408363 *Terms of Use

Device Description: Circular shape TENS/EMS Electrode Pads includes specification of Φ15, Φ20, Φ22, Φ25, Φ30, Φ32, Φ35, Φ40, Φ45, Φ50, Φ52, Φ55, Φ60, Φ64, Φ65, Φ70, Φ75, Φ80, Φ90, Φ100, Φ110, Φ115, Φ120, Φ130, Φ135, Φ150, Φ160

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:	Yes
Prescription Use (Rx):	Yes
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?
35995	Transcutaneous electrical stimulation electrode, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181234	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: e4def046-8c3b-4440-8e40-39227057f54d
Public Version Date: August 16, 2023
Public Version Number: 1
DI Record Publish Date: August 08, 2023