Duns Number:439770017
Device Description: Disposable fully gelled ready to use electrodes, 35x45mm doimensions. P Disposable fully gelled ready to use electrodes, 35x45mm doimensions. PG470/500/US model is especially indicated in electrotherapy. High material flexibility permits to apply electrodes very easily on treating areas. Solid gel maintains unchanged the electrode adhesion and conductivity, during procedure. The products are Latex free
Catalog Number
PG470/500/US
Brand Name
NA
Version/Model Number
PG470/500/US
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K091163,K091163
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
c103422f-166b-4e36-8d58-c4edb559e969
Public Version Date
October 04, 2021
Public Version Number
3
DI Record Publish Date
June 12, 2020
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. | 42 |