Zewa

GUDID 00682891210517

Electrodes 2"x2" (8pcs.)

ZEWA, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00682891210517
• NIH Device Record Key: aa051bed-f69e-44c1-b878-94d25a433d3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zewa
• Version Model Number: 21051
• Company DUNS: 013481078
• Company Name: ZEWA, INC.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682891210517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-05

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