Duns Number:957536014
Device Description: Quell Electrodes Retail - 1 Month supply (1 pack electrodes with UDI 00851221006018 or UDI Quell Electrodes Retail - 1 Month supply (1 pack electrodes with UDI 00851221006018 or UDI 00851221006049 in shipping box)
Catalog Number
-
Brand Name
QUELL
Version/Model Number
QE-ELR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K140586,K140586
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
1075b5fd-821d-4bc0-89f7-63cd31d1c0a6
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
September 08, 2016
Package DI Number
20851221006036
Quantity per Package
12
Contains DI Package
00851221006032
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |