FDA.report

Monoart

Primary DI
E307229101072
Brand
Monoart
Company
EURONDA SPA
Model
MONOART EM21
Catalog number
22910107
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:11 mm. Length: 129 mm. Box of 10 pieces of the same colour. Colour: blue
Published
2019-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E307229101071PackageHIBCC10In Commercial Distribution
E307229101072PackageHIBCC10In Commercial Distribution
E307229101070PrimaryHIBCC0

GMDN Terms

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

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 DIBrandModelCatalogPublished
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
E307220300030MonoartMonoart Bib Up!22030003 2025-04-10
E307220300041MonoartMonoart Bib Up!22030004 2025-04-10
E307220300050MonoartMonoart Bib Up!22030005 2025-04-10
E307220300060MonoartMonoart Bib Up!22030006 2025-04-10
E307220300071MonoartMonoart Bib Up!22030007 2025-04-10
E307220300080MonoartMonoart Bib Up!22030008 2025-04-10
E307220300090MonoartMonoart Bib Up!22030009 2025-04-10
E307220300101MonoartMonoart Bib Up!22030010 2025-04-10
E307220300111MonoartMonoart Bib Up!22030011 2025-04-10
E30722810003EM45 SurgiFlexo TipEM45228100032024-12-04
E3072170111Monoart Monoart Face Mask Protection Soft2170112022-03-18
E3072171120Monoart Monoart Face Mask Protection 32171122018-11-29
E3072171140MonoartMonoart Face Mask Protection 32171142018-11-29

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