Duns Number:694699723
Device Description: The EUSRA RF Electrode is a sterile, single-use electrosurgical accessory intended to be u The EUSRA 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
-
Brand Name
EUSRA RF Electrode
Version/Model Number
19-05E
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
K181249,K181249,K181249
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
db79b891-8ac3-4b41-8969-cbbe491f8030
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 28, 2018
Package DI Number
28809306766605
Quantity per Package
10
Contains DI Package
08809306766601
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 |