AccessGUDID - DEVICE: GoldSelect™ (10816843020238)

GUDID

Device Identifier (DI) Information

Brand Name: GoldSelect™
Version or Model: 003772-25
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ROCHESTER ELECTRO-MEDICAL, INC.

Primary DI Number: 10816843020238
Issuing Agency: GS1
Commercial Distribution End Date: October 19, 2018
Device Count: 25
Labeler D-U-N-S® Number*: 068156330 *Terms of Use

Device Description: DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 6 FT. (1.8 M), SINGLE, PVC WIRE (25/PACK)

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?
11440	Analytical scalp electrode, single-use	A noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	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: 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: fae0a0c3-b242-4288-804c-4ce209ef801b
Public Version Date: October 22, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016