Duns Number:079375431
Device Description: MCKA2-17-50-2 AVNS,MULTI-RF,RFQKIT,,17GX50,1
Catalog Number
MCKA2-17-50-2
Brand Name
AVANOS
Version/Model Number
MCKA2-17-50-2
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
-
Product Code
GXI
Product Code Name
Probe, radiofrequency lesion
Public Device Record Key
19e394eb-caf2-4a48-87ed-32f948e7c98d
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
March 11, 2021
Package DI Number
10193493478924
Quantity per Package
12
Contains DI Package
00193493478927
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 |