Duns Number:828331616
Device Description: TENS Electrodes
Catalog Number
-
Brand Name
ACP High Conductivity Electrodes 2X4
Version/Model Number
21227
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"
Yes
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
-
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
45024fca-e228-46d4-af36-13889feb5aa5
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
August 02, 2016
Package DI Number
10858703006167
Quantity per Package
10
Contains DI Package
00858703006160
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |