ELITONE URGE

GUDID 00851096008100

Muscle stimulator for the treatment of urge urinary incontinence.

ELIDAH, INC.

Transcutaneous incontinence-control electrical stimulator

• Primary Device ID: 00851096008100
• NIH Device Record Key: 1c43537a-61cd-4a18-90d6-ee97b1c58bdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELITONE URGE
• Version Model Number: EK-1016
• 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: false
• 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	00851096008100 [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: 2023-04-21
• Device Publish Date: 2023-04-13

Devices Manufactured by ELIDAH, INC.

• 00851096008100 - ELITONE URGE: 2023-04-21Muscle stimulator for the treatment of urge urinary incontinence.
• 00851096008100 - ELITONE URGE: 2023-04-21 Muscle stimulator for the treatment of urge urinary incontinence.
• 00851096008025 - ELITONE: 2021-04-16 ELITONE GelPads are transcutaneous electrodes to be used with the ELITONE Device.
• 00851096008001 - Elitone: 2019-04-09 Elitone GelPads are transcutaneous electrodes to be used with the Elitone Device.
• 00851096008018 - Elitone: 2019-04-09 Muscle stimulator for the treatment of stress urinary incontinence