Primary Device ID | 00851096008018 |
NIH Device Record Key | d3a2d4fd-c395-4783-b4f8-476d1a63adc3 |
Commercial Distribution Discontinuation | 2019-04-01 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Elitone |
Version Model Number | EK-1006 |
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 | 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 | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851096008018 [Primary] |
QAJ | Cutaneous Electrode Stimulator For Urinary Incontinence |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-09 |
Device Publish Date | 2019-04-01 |
00851096008018 | Muscle stimulator for the treatment of stress urinary incontinence |
00851096008001 | Elitone GelPads are transcutaneous electrodes to be used with the Elitone Device. |
00851096008025 | ELITONE GelPads are transcutaneous electrodes to be used with the ELITONE Device. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ELITONE 87363231 5313764 Live/Registered |
Elidah, Inc. 2017-03-08 |