FDA.reportPublic FDA data

MediSourceNet, Inc

Primary DI
10850034735044
Brand
MediSourceNet, Inc
Company
Medisourcenet, Inc
Model
REGL
Device description
REGL - Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' 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
10850034735044PackageGS120In Commercial Distribution
00850034735047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003473504410850034735044
00850034735047008500347350478500347350470850034735047

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
10850034735051MediSourceNet, IncREGLI2021-08-30
10850034735068MediSourceNet, IncREGLI-52021-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH81Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH82Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH83Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH84Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH85Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
B354OSCVORTH89Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGEI2026-10-19
00860016247000Super PencilRF KINETICS LLCGEI2026-10-17
00860016247017Super PencilRF KINETICS LLCGEI2026-10-17
00860016247024Super PencilRF KINETICS LLCGEI2026-10-17
00860016247031Super PencilRF KINETICS LLCGEI2026-10-17
00841019124017KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124024KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124048KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124079KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124086KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124093KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124109KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124116KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124123KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
00841019124130KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-10-16
10381780533276Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
10381780533283Codman®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEI2026-10-15
00190776435028MillenniumAvalign Technologies, Inc.GEI2026-10-14
00190776434878MillenniumAvalign Technologies, Inc.GEI2026-10-13
08800142924491OsteoBlate™RF Medical Co.,Ltd.GEI2026-10-13
00190776434656MillenniumAvalign Technologies, Inc.GEI2026-10-12
B108890APMMUS00EMFACE controllerBTL INDUSTRIES LIMITEDGEI2026-10-12
B108890APSMUS00EXION Face applicatorBTL INDUSTRIES LIMITEDGEI2026-10-12