AccessGUDID - DEVICE: Uni-Patch (10884521168022)

GUDID

Device Identifier (DI) Information

Brand Name: Uni-Patch
Version or Model: EP84770
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EP84770
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521168022
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 4
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: R Series Stimulating Electrodes,650, Carbon, 25 Gel

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?
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 [?]
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
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Width: 2 Inch
Length: 1.5 Inch

Device Record Status

Public Device Record Key: 3e2cedee-5d49-4703-bede-1bb3d00c857b
Public Version Date: September 04, 2023
Public Version Number: 9
DI Record Publish Date: September 24, 2016