Duns Number:439770017
Device Description: PG471W/US are disposable adhesive electrodes with solid conductive gel. High material flex PG471W/US are disposable adhesive electrodes with solid conductive gel. High material flexibility permits to apply electrodes very easily on treating areas. Solid gel maintains unchanged the electrode adhesion and conductivity, during procedure. The electrodes 46x47mm dimensions are equipped with a 10 cm long cable, with 2mm socket. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient’s skin. The electrodes are non-sterile and for single patient use only. Latex free.
Catalog Number
PG471W/US
Brand Name
NA
Version/Model Number
PG471W/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
d5d97621-e361-44b7-9fea-964a86ea051c
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
June 10, 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 |