Duns Number:608625823
Device Description: The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reproc The device is the Covidien ClosureRFS Endovenous Radiofrequency (RF) Stylet that is reprocessed by Northeast Scientific, Inc.
Catalog Number
R-RFS2-6-12
Brand Name
NES Reprocessed RF Stylet (RFS)
Version/Model Number
R-RFS2-6-12
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 02, 2018
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
K173214
Product Code
NUJ
Product Code Name
Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Public Device Record Key
be683057-21e8-49d5-ac2e-786826c46418
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 01, 2018
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 |