AccessGUDID - DEVICE: Dry Flex-T (B675DRYFLEXT1)

GUDID

Device Identifier (DI) Information

Brand Name: Dry Flex-T
Version or Model: ZP-200-43211
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ZP-200-43211
Company Name: ZETO, INC.

Primary DI Number: B675DRYFLEXT1
Issuing Agency: HIBCC
Commercial Distribution End Date: November 10, 2023
Device Count: 10
Labeler D-U-N-S® Number*: 079582566 *Terms of Use

Device Description: Dry Flex Electrodes - Bristle Tall

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):	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 [?]
K172735	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
Special Storage Condition, Specify: Store in cool, dry place, away from direct sunlight

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Bristle, Tall

Device Record Status

Public Device Record Key: 6b91393e-bca2-4b9e-bfd1-e52b23f28da0
Public Version Date: May 28, 2026
Public Version Number: 4
DI Record Publish Date: January 25, 2021