FDA.reportPublic FDA data

Monoart

Primary DI
E307226101021
Brand
Monoart
Company
EURONDA SPA
Model
MONOART® COTTON ROLLS
Catalog number
22610102
Device description
Cotton rolls Monoart No. 2 diameter 10 mm, length 37 mm. Bag of 300 gr.
Published
2019-12-17
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

Product Codes#

Code, Name table
CodeName
EFNCotton, Roll

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFNCotton, RollDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E307226101021PackageHIBCC60In Commercial Distribution
E307226101020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cotton rollA non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.

Sterilization Methods#

Method table
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 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
00810194401657AiraAIRA, LLCEFN2026-01-16
00810194401794AiraAIRA, LLCEFN2026-01-16
00810124536909Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-12-05
50732224001086Ultra Gauze Non-Woven SpongesCROSSTEX INTERNATIONAL, INC.EFN2025-10-23
00810124531843Avaline Medical NJ LLCAvaline Medical NJ Limited Liability CompanyEFN2025-09-03
00810132808203House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
10810132808200House Brand DentistryFrontier Dental Supply IncEFN2025-08-05
00840456214947JMUJMU DENTAL, INCEFN2025-07-15
00840456214954JMUJMU DENTAL, INCEFN2025-07-15
00840456214961JMUJMU DENTAL, INCEFN2025-07-15
00840456214978JMUJMU DENTAL, INCEFN2025-07-15
00810132044281HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
20810132044285HCS SourcingConcordance Healthcare Solutions LLCEFN2025-04-07
00810132044274HCSConcordance Healthcare Solutions LLCEFN2025-03-05
20810132044278HCSConcordance Healthcare Solutions LLCEFN2025-03-05
D77810701991Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
D77810701992Scott's Select Cotton RollsSCOTT'S DENTAL SUPPLY L.L.C.EFN2024-08-27
10304040184803Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184810Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184827Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184858Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10304040184865Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184806Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184813Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184820Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184851Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
00304040184868Henry ScheinHENRY SCHEIN, INC.EFN2024-08-15
10850053289535SURGYCOSurgyco LLCEFN2024-08-09
10850053289542SURGYCOSurgyco LLCEFN2024-08-09
00850053289538SURGYCOSurgyco LLCEFN2024-08-09