FDA.reportPublic FDA data

Monoart

Primary DI
E307229300010
Brand
Monoart
Company
EURONDA SPA
Model
MONOART EM19
Catalog number
22930001
Device description
Universal tips for surgical aspirators, recommended for procedures on adults. Ergonomic, non-slip grips and linear shape to keeps them quiet and promotes better hygiene and cleaning. They can be sterilized in autoclaves at up to 134°C. Connection diameter:16 mm. Length: 114 mm. Box of 10 pieces of the same colour. Colour: grey.
Published
2019-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E307229300011PackageHIBCC10In Commercial Distribution
E307229300012PackageHIBCC10In Commercial Distribution
E307229300010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, reusableA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is made of metal or plastic materials that can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428755441
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E307232300200MonoartMONOART INSTANT ICE232300202019-07-26
E3072709230AlleIRRIGATION SET FOR MACHINERY2709232025-10-31
E3072709250AlleIRRIGATION SET FOR MACHINERY2709252025-10-31
E3072170120Monoart Monoart Face Mask Protection Graffiti2170122025-04-10
E3072170130Monoart Monoart Face Mask Protection Graffiti2170132025-04-10
E3072170140Monoart Monoart Face Mask Protection Graffiti2170142025-04-10
E3072170150Monoart Monoart Face Mask Protection Graffiti2170152025-04-10
E307220300010MonoartMonoart Bib Up!220300012025-04-10
E307220300020MonoartMonoart Bib Up!22030002 2025-04-10
E307220300040MonoartMonoart Bib Up!22030004 2025-04-10
E307220300070MonoartMonoart Bib Up!22030007 2025-04-10
E307220300100MonoartMonoart Bib Up!22030010 2025-04-10
E307220300110MonoartMonoart Bib Up!22030011 2025-04-10
E3072170121Monoart Monoart Face Mask Protection Graffiti2170122025-04-10
E3072170131Monoart Monoart Face Mask Protection Graffiti2170132025-04-10
E3072170141Monoart Monoart Face Mask Protection Graffiti2170142025-04-10
E3072170151Monoart Monoart Face Mask Protection Graffiti2170152025-04-10
E307220300000MonoartMonoart Bib Up!220300002025-04-10
E307220300011MonoartMonoart Bib Up!220300012025-04-10
E307220300021MonoartMonoart Bib Up!22030002 2025-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G453332414200PEAK MEDICALPeak Medical Distribution Inc.GEA2026-05-08
G589DS22G501DermaSculptCosmoFranceGEA2026-04-13
G589DS22G701DermaSculptCosmoFranceGEA2026-04-13
G589DS23G301DermaSculptCosmoFranceGEA2026-04-13
G589DS23G401DermaSculptCosmoFranceGEA2026-04-13
G589DS23G501DermaSculptCosmoFranceGEA2026-04-13
G589DS25G401DermaSculptCosmoFranceGEA2026-04-13
G589DS25G501DermaSculptCosmoFranceGEA2026-04-13
G589DS27G251DermaSculptCosmoFranceGEA2026-04-13
G589DS27G401DermaSculptCosmoFranceGEA2026-04-13
G589DS27G501DermaSculptCosmoFranceGEA2026-04-13
G589DS30G251DermaSculptCosmoFranceGEA2026-04-13
10192253037906MonojectCardinal Health 200, LLCGEA2026-04-07
10192253037913MonojectCardinal Health 200, LLCGEA2025-10-10
10669808004008SoftFil® EasyGuideProllenium MedicalGEA2025-08-28
10669808004084SoftFil® PrecisionProllenium MedicalGEA2025-08-28
10192253003444ArgyleCardinal Health 200, LLCGEA2024-10-09
10192253003451ArgyleCardinal Health 200, LLCGEA2024-10-09
10850013527028DannikDannik LLCGEA2023-01-21
10850013527073DannikDannik LLCGEA2023-01-21
10850013527080DannikDannik LLCGEA2023-01-21
10850013527097DannikDannik LLCGEA2023-01-21
10850013527103DannikDannik LLCGEA2023-01-21
10850013527110DannikDannik LLCGEA2023-01-21
10850013527127DannikDannik LLCGEA2023-01-21
10850013527134DannikDannik LLCGEA2023-01-21
10850013527141DannikDannik LLCGEA2023-01-21
10850013527158DannikDannik LLCGEA2023-01-21
10850013527165DannikDannik LLCGEA2023-01-21
10850013527172DannikDannik LLCGEA2023-01-21