AccessGUDID - DEVICE: Paragon Super Stim Electrodes (00866811000222)

GUDID

Device Identifier (DI) Information

Brand Name: Paragon Super Stim Electrodes
Version or Model: 2" x 2" Foam Electrodes
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 442722
Company Name: PARAGON REHAB SUPPLIES LLC

Primary DI Number: 00866811000222
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080255394 *Terms of Use

Device Description: No description.

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):	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?
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 [?]
K130987	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
Storage Environment Temperature: between 41 and 80.6 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4a6ef780-6d0b-45ef-b336-74d36391b756
Public Version Date: February 19, 2021
Public Version Number: 4
DI Record Publish Date: July 13, 2016