Elitone URGE

GUDID 00851096008117

Elitone URGE Therapy Kit, includes 1x Elitone URGE (00851096008100) and 2x Elitone GelPad packs (00851096008032)

ELIDAH, INC.

Transcutaneous incontinence-control electrical stimulator

• Primary Device ID: 00851096008117
• NIH Device Record Key: a1636e51-ebf5-4926-b5b0-e82c118c9710
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elitone URGE
• Version Model Number: EK-1019
• Company DUNS: 079300140
• Company Name: ELIDAH, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851096008117 [Primary]

FDA Product Code

• QAJ: Cutaneous Electrode Stimulator For Urinary Incontinence

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: 2024-12-27
• Device Publish Date: 2024-12-19

On-Brand Devices [Elitone URGE]

• 00851096008100: Muscle stimulator for the treatment of urge urinary incontinence.
• 00851096008117: Elitone URGE Therapy Kit, includes 1x Elitone URGE (00851096008100) and 2x Elitone GelPad packs