Duns Number:116956807
Device Description: 4" x 7" pigtail electrode
Catalog Number
EERC400700
Brand Name
4" x 7" pigtail electrode
Version/Model Number
EERC400700
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"
-
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
7c2de414-5afb-4c55-afc3-d527a683e9d6
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
10857771003313
Quantity per Package
10
Contains DI Package
00857771003316
Package Discontinue Date
-
Package Status
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 |