WAVi Co.

GUDID B592WH300

WAVI CO.

Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode Analytical non-scalp cutaneous electrode

Primary Device ID	B592WH300
NIH Device Record Key	bc54da26-2c48-4a88-957d-fdaa552d0460
Commercial Distribution Status	In Commercial Distribution
Brand Name	WAVi Co.
Version Model Number	WH300
Company DUNS	007785282
Company Name	WAVI CO.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B592WH300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162460

FDA Product Code

GXY	Electrode, Cutaneous

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-03-19
Device Publish Date	2019-03-11

On-Brand Devices [WAVi Co.]

B592WH500	WH500
B592WH400	WH400
B592WH300	WH300
B592WE200	WE200
B592WE100	WE100