AccessGUDID - DEVICE: Two Channel Electroglottograph EG2-PCX2 (00860011116905)

GUDID

Device Identifier (DI) Information

Brand Name: Two Channel Electroglottograph EG2-PCX2
Version or Model: EG2-PCX2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Glottal Enterprises, Inc.

Primary DI Number: 00860011116905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 114191554 *Terms of Use

Device Description: Device for the non-invasive measurement of vocal fold contact area.

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):	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?
16034	Electroglottograph	A graphic recorder designed for recording the changes in electrical potential or impedance, using a sensor, resulting from movement of the vocal cords during respiration and phonation. It is intended to be used to asses the degree of closure of the vocal cords during treatment of voice disorders and in the study of the laryngeal mechanism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLX	Electroglottograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K901609	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: 62bcbbce-9e45-4351-9c53-0b7b7b676e0a
Public Version Date: July 09, 2024
Public Version Number: 1
DI Record Publish Date: July 01, 2024