Duns Number:135741127
Device Description: 4" Round Silicone Electrodes (1 pack = 2 electrodes per pack)
Catalog Number
ProM-054R
Brand Name
Pro-Med
Version/Model Number
ProM-054R
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 31, 2025
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
K132998
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
2a2ab9e1-f381-4fbb-a8c3-c8fc409a580c
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
October 24, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |