AccessGUDID - DEVICE: Alpha-Stim Earclip Electrode Pad (00857869005031)

GUDID

Device Identifier (DI) Information

Brand Name: Alpha-Stim Earclip Electrode Pad
Version or Model: EEP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Electromedical Products International, Inc.

Primary DI Number: 00857869005031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 610954729 *Terms of Use

Device Description: Alpha-Stim Earclip Electrode Pad

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):	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?
61170	Electrical probe/electrode conductive pad	A small, non-sterile device designed to facilitate electrical conduction between an electrical stimulation probe or electrode and the skin. It is typically contoured to fit on a particular type of probe/electrode and is made of an absorbent material (e.g., felt) that may be soaked in a conduction fluid. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JXK	Stimulator, Cranial Electrotherapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: c6fbb0e2-ea67-42d6-a386-7380f2dc39db
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 25, 2014