Duns Number:211334261
Device Description: The Swift® interconnect cable connects the Swift® handpiece with the Swift® microwave gene The Swift® interconnect cable connects the Swift® handpiece with the Swift® microwave generator.
Catalog Number
SWF-CA01
Brand Name
Swift® Interconnect Cable
Version/Model Number
SWF-CA01
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K181941
Product Code
NEY
Product Code Name
System, Ablation, Microwave And Accessories
Public Device Record Key
fb8e53d3-7932-46ba-9039-af50b6445620
Public Version Date
February 04, 2019
Public Version Number
1
DI Record Publish Date
January 02, 2019
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. | 5 |