Duns Number:149818952
Device Description: Radiofrequency Cannula - Straight
Catalog Number
SMK-S1010-22
Brand Name
SMK™
Version/Model Number
SMK-S1010-22
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
efbf5164-c931-42c5-8af4-af8f66915a9e
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
April 10, 2017
Package DI Number
15415067028799
Quantity per Package
10
Contains DI Package
05415067028792
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |