Duns Number:116956807
Device Description: 20 per pouch
Catalog Number
EDRC225250
Brand Name
2.25" x 2.50" electrode
Version/Model Number
EDRC225250
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 14, 2020
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)
-
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
3c64288c-e795-481b-94a2-7161d4390387
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
10857771003306
Quantity per Package
100
Contains DI Package
00857771003309
Package Discontinue Date
October 14, 2020
Package Status
Not in Commercial Distribution
Package Type
inner pack
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 80 |