AccessGUDID - DEVICE: Self-Adhesive Electrode 2" x 4" Pro Pulse HD (B243PSSA2X4PP4)

GUDID

Device Identifier (DI) Information

Brand Name: Self-Adhesive Electrode 2" x 4" Pro Pulse HD
Version or Model: 0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ELECTRO MEDICAL TECHNOLOGIES, LLC

Primary DI Number: B243PSSA2X4PP4
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 160641309 *Terms of Use

Device Description: Self-Adhesive Electrode

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):	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?
35955	Transdermal medication patch	A medication-impregnated device designed as a skin patch that is fixed to the skin, typically with a pressure-sensitive adhesive, for dermal absorption of the medication (e.g., pain relief local anaesthetic agent). 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6020e8d4-d262-4938-8952-11fb5c8efb75
Public Version Date: July 12, 2022
Public Version Number: 5
DI Record Publish Date: September 23, 2016