Duns Number:080930531
Device Description: 2" Round, Foam
Catalog Number
-
Brand Name
EZ-Stick
Version/Model Number
201-128
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 31, 2018
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
a25aaed0-5a2f-43d6-b9d2-498faf719a5f
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
November 18, 2016
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 | 47 |
2 | A medical device with a moderate to high risk that requires special controls. | 449 |