Duns Number:066689993
Device Description: SELF-ADHERING TENS ELECTRODES, 2 INCHES BY 2 INCHES. 4PCS.
Catalog Number
NPP822U10
Brand Name
RESERV
Version/Model Number
NPP822U10
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)
Yes
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
21ad57b0-ca21-4998-bba8-a520c177875a
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
January 19, 2018
Package DI Number
10815991021463
Quantity per Package
10
Contains DI Package
00815991021466
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner, poly bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |