Duns Number:608625823
Device Description: The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-100) is intended The NES Reprocessed Varicose Vein RF Catheter (Covidien Closurefast CF7-7-100) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
Catalog Number
R-CF7-7-100
Brand Name
NES Reprocessed Varicose Vein RF Catheter
Version/Model Number
CF7-7-100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
NUJ
Product Code Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Public Device Record Key
bf34ec93-37e2-4453-b731-c0eb32c44caa
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 29, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |