FDA.reportPublic FDA data

MediSourceNet, Inc

Primary DI
00850034735061
Brand
MediSourceNet, Inc
Company
Medisourcenet, Inc
Model
REGLI-5
Device description
REGLI-5 : Regular Non-Extendable Smoke Evacuation Pencil, Insulated 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
10850034735068PackageGS120In Commercial Distribution
00850034735061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003473506810850034735068
00850034735061008500347350618500347350610850034735061

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
00850034735078MediSourceNet, IncREGL-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
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14