AccessGUDID - DEVICE: UltraPoly 2" Round (10660584000659)

GUDID

Device Identifier (DI) Information

Brand Name: UltraPoly 2" Round
Version or Model: 7B0281
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Dynatronics Corporation

Primary DI Number: 10660584000659
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 113399125 *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):	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 [?]
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
Area/Surface Area: 3.14 Square inch

Device Record Status

Public Device Record Key: 7c623214-b997-4029-a2d8-94ad651c0cbe
Public Version Date: October 31, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016