FDA.reportPublic FDA data

MediSourceNet, Inc

Primary DI
00850034735078
Brand
MediSourceNet, Inc
Company
Medisourcenet, Inc
Model
REGL-5
Device description
REGL-5 : Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092732000
K143103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092732000PROPENCIL ESU PENCILBio Protech, Inc.2009-11-25GEI
K143103000PROPENCIL Smoke PencilBio Protech, Inc.2015-07-16GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850034735075PackageGS120In Commercial Distribution
00850034735078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003473507510850034735075
00850034735078008500347350788500347350780850034735078

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical handpiece/electrode, monopolar, reusableA 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 reusable device.

Regulatory Flags#

DUNS number
118269952
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850034735160MediSourceNet, IncKWV-StarterKit2023-08-14
00850034735153MediSourceNet, IncMSNCF222022-09-06
00850034735146MediSourceNet, IncP9552F-MSN2022-09-06
10850034735150MediSourceNet, IncMSNCF222022-09-06
00850034735047MediSourceNet, IncREGL2021-08-30
00850034735054MediSourceNet, IncREGLI2021-08-30
00850034735061MediSourceNet, IncREGLI-52021-08-30
00850034735085MediSourceNet, IncEXTL2021-08-30
00850034735092MediSourceNet, IncEXTLI2021-08-30
00850034735108MediSourceNet, IncEXTL-52021-08-30
00850034735115MediSourceNet, IncEXTLI-52021-08-30
00850034735122MediSourceNet, IncWELF2021-08-30
00850034735139MediSourceNet, IncWELF-52021-08-30
00850034735009MediSourceNet, IncKWV-M2021-08-30
00850034735016MediSourceNet, IncKWV-DT2021-08-30
00850034735023MediSourceNet, IncKWV-F2021-08-30
00850034735030MediSourceNet, IncKWV-LT2021-08-30
10850034735044MediSourceNet, IncREGL2021-08-30
10850034735051MediSourceNet, IncREGLI2021-08-30
10850034735068MediSourceNet, IncREGLI-52021-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006051Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006068Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006143Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006150Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006167Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006174Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006181Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006198Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006211Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006242Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006266Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006273Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006310Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006341Triple Footswitch & CableELLIQUENCE, LLCGEI2026-06-02
00846338007133Trigger-Flex Quad Pro Bipolar SystemELLIQUENCE, LLCGEI2026-06-02
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-02
00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004729Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004736Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01