Primary Device ID | 00851096008025 |
NIH Device Record Key | c5425c71-00e3-44a2-9299-f8e1835b50de |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ELITONE |
Version Model Number | EE-1011 |
Company DUNS | 079300140 |
Company Name | ELIDAH, INC. |
Device Count | 5 |
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 |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com | |
Phone | 978-435-4324 |
customercare@elitone.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851096008025 [Unit of Use] |
GS1 | 00851096008032 [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 | 2021-04-16 |
Device Publish Date | 2021-04-08 |
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 |