Duns Number:054152269
Device Description: Scrip Hessco Reusable Electrodes 2" X 3.5" 4/pkg
Catalog Number
-
Brand Name
Scrip Hessco
Version/Model Number
672 0018
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
Yes
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
K130987
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
c8ccffe1-92c7-457b-8136-95e85f36c6f8
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
May 23, 2017
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. | 10 |