Duns Number:009831413
Device Description: Pro Advantage Electrode Foam 2 3/4 Round 4PK
Catalog Number
P850093
Brand Name
Pro Advantage
Version/Model Number
P850093
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130987,K130987
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
5185bfa2-8348-467a-be34-a24ae94991f5
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
February 13, 2017
Package DI Number
M220P8500935
Quantity per Package
40
Contains DI Package
M220P8500932
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |