FDA.reportPublic FDA data

Monoart

Primary DI
E307219101300
Brand
Monoart
Company
EURONDA SPA
Model
MONOART APRON PG20
Catalog number
21910130
Device description
Roll of 200 patients aprons made from a waterproof polyethylene layer. Size 810x530 mm. Carton of 6 rolls. Colour: green.
Published
2019-12-16
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
KHRAbsorber, Saliva, Paper

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E307219101301PackageHIBCC6In Commercial Distribution
E307219101302PackageHIBCC200In Commercial Distribution
E307219101300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient examination/treatment drape, single-useA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during an examination or non-surgical treatment procedure in the home or healthcare facility primarily to prevent soiling/cross-contamination; it is not intended for surgical use. This is a single-use 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
00840456217696JMUJMU DENTAL, INCKHR2026-06-05
00840456222188JMUJMU DENTAL, INCKHR2026-06-05
00840456222195JMUJMU DENTAL, INCKHR2026-06-05
00840456223000JMUJMU DENTAL, INCKHR2026-06-05
00840456223017JMUJMU DENTAL, INCKHR2026-06-05
00840456201756JMUJMU DENTAL, INCKHR2026-05-27
00840456201763JMUJMU DENTAL, INCKHR2026-05-27
00840456201770JMUJMU DENTAL, INCKHR2026-05-27
00840456201787JMUJMU DENTAL, INCKHR2026-05-27
00840456201794JMUJMU DENTAL, INCKHR2026-05-27
00840456221020JMUJMU DENTAL, INCKHR2026-05-27
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10371347011460Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011477Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011484Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011491Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
10371347011507Advance Dental ProductsThe Atlanta Dental Supply CompanyKHR2024-02-09
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