Duns Number:079375431
Device Description: COOLIEF* SINERGY* Cooled Radiofrequency Probe Kit
Catalog Number
SIK-17-150-4
Brand Name
AVANOS
Version/Model Number
SIK-17-150-4
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053082,K053082
Product Code
GXI
Product Code Name
Probe, radiofrequency lesion
Public Device Record Key
bb2f60c4-ee9f-41bf-9aa5-bc3607efc58f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
October 16, 2020
Package DI Number
10193493997142
Quantity per Package
2
Contains DI Package
00193493997145
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |