Duns Number:080015502
Device Description: EEG Single Disc Electrodes, 10mm CAST PURE SILVER/60" COLORED WIRES/(10)
Catalog Number
SH-60S
Brand Name
The Electrode Store
Version/Model Number
SH-60S
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K022197
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
46edd0d8-0a4f-4fe9-822c-92d0a8c6534b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 166 |