FDA.report

Monoart

Primary DI
E307219101321
Brand
Monoart
Company
EURONDA SPA
Model
MONOART APRON PG20
Catalog number
21910132
Device description
Roll of 200 patients aprons made from a waterproof polyethylene layer. Size 810x530 mm. Carton of 6 rolls. Colour: white
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
KHRAbsorber, Saliva, Paper

Product Code Classifications

CodeDeviceSpecialtyClass
KHRAbsorber, Saliva, PaperDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E307219101321PackageHIBCC6In Commercial Distribution
E307219101322PackageHIBCC200In Commercial Distribution
E307219101320PrimaryHIBCC0

GMDN Terms

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

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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00840456202760JMUJMU DENTAL, INCKHR2025-12-11
00840456202777JMUJMU DENTAL, INCKHR2025-12-11
00840456202784JMUJMU DENTAL, INCKHR2025-12-11
00840456215142JMUJMU DENTAL, INCKHR2025-12-11
00840456215159JMUJMU DENTAL, INCKHR2025-12-11
00840456215609JMUJMU DENTAL, INCKHR2025-12-11
00840456215616JMUJMU DENTAL, INCKHR2025-12-11
00840456217191JMUJMU DENTAL, INCKHR2025-12-11
00840456217207JMUJMU DENTAL, INCKHR2025-12-11
00840456217214JMUJMU DENTAL, INCKHR2025-12-11
00840456217221JMUJMU DENTAL, INCKHR2025-12-11
00840456217238JMUJMU DENTAL, INCKHR2025-12-11
00840456217245JMUJMU DENTAL, INCKHR2025-12-11
00840456217252JMUJMU DENTAL, INCKHR2025-12-11
00840456217269JMUJMU DENTAL, INCKHR2025-12-11
00840456217276JMUJMU DENTAL, INCKHR2025-12-11
00840456217283JMUJMU DENTAL, INCKHR2025-12-11
00840456217290JMUJMU DENTAL, INCKHR2025-12-11
00840456217306JMUJMU DENTAL, INCKHR2025-12-11
00840456217313JMUJMU DENTAL, INCKHR2025-12-11