Duns Number:694699723
Device Description: Single: Enables and disables RF output in manual control modeDouble: Increases(right) and Single: Enables and disables RF output in manual control modeDouble: Increases(right) and decreases(left) RF output in 5watt step in manual control mode
Catalog Number
-
Brand Name
Foot switch Single and Double
Version/Model Number
FS01-02R + FS02-01R
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K163450
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
f6958265-cf58-48fd-8362-96973c49a23e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 02, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |