FDA.reportPublic FDA data

MediSourceNet, Inc

Primary DI
10850034735112
Brand
MediSourceNet, Inc
Company
Medisourcenet, Inc
Model
EXTLI-5
Device description
EXTLI-5 : 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
Rx
false
OTC
false
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092732000PROPENCIL ESU PENCILBio Protech, Inc.2009-11-25GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850034735112PackageGS120In Commercial Distribution
00850034735115PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003473511210850034735112
00850034735115008500347351158500347351150850034735115

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118269952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
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00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004729Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004736Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01