FDA.reportPublic FDA data

NOVA LED Light Source Pencil

Primary DI
HS101125
Brand
NOVA LED Light Source Pencil
Company
Pare Surgical, Inc
Model
Hand Switching
Catalog number
900018
Device description
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.
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
HS112ESUPENCILSPackageHIBCC12In Commercial Distribution
HS101125PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, single-useA rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit120 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
13036890187fleenor@pare.net

Regulatory Flags#

DUNS number
949432546
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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Primary DI, Brand, Company table
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