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Monoart

FDA UDI

Class I (US FDA UDI)

by Euronda Spa

Identity

Trade Name
Monoart FDA UDI
Generic Name
Dental suction system cannula, single-use FDA UDI
Device Name
Disposable, flexible saliva ejectors made of non-toxic, transparent PVC. Fix rounded tips. Integrated metal wire. Diameter 6,5 mm. Bag of 100 pcs. Box of 5.000 pcs. Color: Burgundy FDA UDI
Model / Reference
MONOART® EM15 SALIVA EJECTOR FDA UDI
Description
Disposable, flexible saliva ejectors made of non-toxic, transparent PVC. Fix rounded tips. Integrated metal wire. Diameter 6,5 mm. Bag of 100 pcs. Box of 5.000 pcs. Color: Burgundy FDA UDI

Identifiers

Catalog Number
22810645 FDA UDI
Primary DI / UDI-DI
E307228106450 FDA UDI
FDA Product Code
DYN FDA UDI
GMDN Term
Dental suction system cannula, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental suction system cannula, single-use

Monoart by Euronda Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental suction system cannula, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Euronda Spa

Sources (1)

  • FDA UDI 7030c021-fbf9-45ad-b72d-f6647e42ab68 34 fields · synced Jun 1, 2026