AccessGUDID - DEVICE: Protekt Titanium Adhesive Pre-Gelled Electrode for TENS

GUDID

Device Identifier (DI) Information

Brand Name: Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Round 3"
Version or Model: PMTENSEL4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PMTENSEL4
Company Name: PROACTIVE MEDICAL PRODUCTS, LLC

Primary DI Number: 05060488570988
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078582655 *Terms of Use

Device Description: Protekt Titanium Adhesive Pre-Gelled Electrode for TENS - Round 3"

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):	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?
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 [?]
K012463	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
Height: 1 Inch
Width: 6 Inch
Length: 4 Inch

Device Record Status

Public Device Record Key: 8cf9f76d-9ece-40c6-8d01-9fdaf95698e7
Public Version Date: February 19, 2021
Public Version Number: 2
DI Record Publish Date: January 01, 2020