WAVi Co.

GUDID B592WE100

WAVI CO.

Analytical non-scalp cutaneous electrode

• Primary Device ID: B592WE100
• NIH Device Record Key: 142e0389-1c55-4e3c-800e-5c1f83c9c0c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVi Co.
• Version Model Number: WE100
• 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: true
• 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	B592WE100 [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