Excel CF

GUDID 00861039000382

2.75" Round Electrode

A. R. DAVIS COMPANY, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00861039000382
• NIH Device Record Key: fbf36479-ac0a-49f6-ae63-d71e02d34bd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Excel CF
• Version Model Number: 579275
• Company DUNS: 847119278
• Company Name: A. R. DAVIS COMPANY, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861039000382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970426

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: 4
• Public Version Date: 2018-09-07
• Device Publish Date: 2016-11-02

On-Brand Devices [Excel CF]

• 00861039000399: 2" x 2" Square Electrode
• 00861039000382: 2.75" Round Electrode
• 00861039000375: 2" Round Electrode