Duns Number:098554157
Catalog Number
-
Brand Name
Cadwell EEG Gold Cup Electrode
Version/Model Number
302767-200
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K933808
Product Code
GXY
Product Code Name
ELECTRODE, CUTANEOUS
Public Device Record Key
e0ae94e9-80ed-4eeb-8bd1-2d8c9eea1d4e
Public Version Date
June 28, 2021
Public Version Number
2
DI Record Publish Date
June 03, 2020
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. | 290 |