FDA.report

Monoart

Primary DI
E3072640000
Brand
Monoart
Company
EURONDA SPA
Model
KIT MONOART DENTIST CHAIR COVER
Catalog number
264000
Device description
A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: light blue
Published
2019-12-16
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
NRUChair, Dental, Without Operative Unit

Product Code Classifications

CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E3072640001PackageHIBCC25In Commercial Distribution
E3072640002PackageHIBCC3In Commercial Distribution
E3072640000PrimaryHIBCC0

GMDN Terms

TermDefinition
Medical equipment drape, single-use, non-sterileA non-sterile flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use 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

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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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