Duns Number:071595540
Device Description: 60MM X 2.3MM DIAMETER, CONCEPT HEATWAVE ELECTRODE, QTY 5
Catalog Number
CS-024
Brand Name
CONCEPT HEATWAVE
Version/Model Number
CS-024
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K991830,K991830,K991830
Product Code
JOS
Product Code Name
Electrode, electrosurgical
Public Device Record Key
ab3b039a-7e16-488e-b167-b962da020505
Public Version Date
June 07, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20845854021863
Quantity per Package
5
Contains DI Package
10845854021866
Package Discontinue Date
June 06, 2022
Package Status
Not in Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |