Duns Number:060121928
Device Description: Multi-Use Electrode, Cloth, Round, 2 3/4" (4)
Catalog Number
-
Brand Name
Norco Multi-Use Electrode, Cloth
Version/Model Number
NC89233
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
K130987
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
5e1d0d11-a7a9-4787-9999-36478499edfe
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
August 16, 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. | 18 |