FDA.reportPublic FDA data

Monoart

Primary DI
E30722910110
Brand
Monoart
Company
EURONDA SPA
Model
MONOART EM40
Catalog number
22910110
Device description
Universal moulded tip for surgical aspirator. It can be sterilised in autoclave at 134°C. Medical Device Class Ila. Connection diameter: 11mm. Lenght: 200mm. Box of 10 pcs. Color: light grey
Published
2019-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
E307229101101PackageHIBCC10Not in Commercial Distribution
E307229101102PackageHIBCC10Not in Commercial Distribution
E30722910110PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
428755441
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
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
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00840217908436Ace Medical CompanyEBNER MEDICAL, LLCGEA2023-10-25
00840217908399Ace Medical CompanyEBNER MEDICAL, LLCGEA2023-10-23
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00840217908382Ace Medical CoEBNER MEDICAL, LLCGEA2023-09-29
00840217908368Ace Medical CompanyEBNER MEDICAL, LLCGEA2023-09-01
00840217908375Ace Medical CompanyEBNER MEDICAL, LLCGEA2023-09-01