Duns Number:949432546
Device Description: The NOVA is a Electrosurgical Pencil that has 3 LED battery powered located at the distal The NOVA is a Electrosurgical Pencil that has 3 LED battery powered located at the distal end for better visualization of the surgical field. The NOVA can be fitted with a smoke shroud that will remove the smoke plume from the site.The device is designed to work with all standard Electrosurgical Generators.
Catalog Number
900018
Brand Name
NOVA LED Light Source Pencil
Version/Model Number
Hand Switching
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
608adffa-dcdb-47f1-99ed-f9102856ee31
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
February 15, 2017
Package DI Number
HS112ESUPENCILS
Quantity per Package
12
Contains DI Package
HS101125
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-