Duns Number:694699723
Device Description: The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be us The VIVA 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, handle and tubing.
Catalog Number
-
Brand Name
VIVA RF Electrode
Version/Model Number
18-08V05-30X_V2
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
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
d3090916-bd3a-43d9-a97e-641be78144d5
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 09, 2021
Package DI Number
18809306762433
Quantity per Package
5
Contains DI Package
08809306762436
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 |