Duns Number:080935429
Device Description: 855 Foam Electrodes,Conductive Adhesive Hydrogel, Radiolucent
Catalog Number
22855
Brand Name
Kendall
Version/Model Number
22855
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 01, 2023
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
6aa35281-2130-4c4f-bf1d-77d01d77f5db
Public Version Date
November 17, 2020
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884527008247
Quantity per Package
600
Contains DI Package
20884527008244
Package Discontinue Date
July 01, 2023
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |