Duns Number:066689993
Device Description: BODYMED SELF-ADHERING ELECTRODES, FABRIC BACK, REUSABLE, 2" X 2" SQUARE, WITH PULL TAB
Catalog Number
NPP22TAB
Brand Name
BodyMed
Version/Model Number
NPP22TAB
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)
-
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
c864022d-43e9-445a-8db7-7a2cbe97d3a3
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
October 14, 2019
Package DI Number
20815991022832
Quantity per Package
520
Contains DI Package
00815991022838
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| 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 |