Duns Number:694699723
Device Description: The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be us The star RF Electrode is a sterile, single-use electrosurgical accessory intended to be used inconjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handleand tubing.
Catalog Number
17-20s30F
Brand Name
star RF Electrode
Version/Model Number
17-20s30F
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
K163450,K163450,K163450
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
a2a598cd-c242-470c-9020-e95be4b1b6f0
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
May 19, 2017
Package DI Number
28809306760559
Quantity per Package
10
Contains DI Package
08809306760555
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |