Duns Number:529401134
Device Description: CWF1005, electrode pad, white foam
Catalog Number
-
Brand Name
NA
Version/Model Number
NA
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160138,K160138,K160138
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
ce6b1797-d659-4980-b573-3bcbf4185cb4
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
September 19, 2017
Package DI Number
06970341677367
Quantity per Package
420
Contains DI Package
06970341670320
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
paper carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 24 |