Identity
- Trade Name
- Monoart FDA UDI
- Generic Name
- Dental cotton roll FDA UDI
- Device Name
- Cotton rolls Monoart No.1 diameter 8 mm, length 37 mm. Bag of 300 gr. FDA UDI
- Model / Reference
- MONOART® COTTON ROLLS FDA UDI
- Description
- Cotton rolls Monoart No.1 diameter 8 mm, length 37 mm. Bag of 300 gr. FDA UDI
Identifiers
- Catalog Number
- 22610101 FDA UDI
- Primary DI / UDI-DI
- E307226101010 FDA UDI
- FDA Product Code
- EFN FDA UDI
- GMDN Term
- Dental cotton roll FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6050 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 cotton roll
Monoart by Euronda Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental cotton roll.
- PureLife+ Cotton Rolls — PURELIFE, LLC · Class I
- PureLife+ Cotton Tip Applicators — PURELIFE, LLC · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- JMU — JMU DENTAL, INC · Class I
- Mirror Cotton Holders — PRACTICON, INC. · Class I
- Plasdent — PLASDENT CORP. · Class I
- Britedent — BRIGHT SUPPLY INC · Class I
- Baru — Baru Foshan medical technology co., Limited · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Euronda Spa
Sources (1)
- FDA UDI 99503b85-9003-4210-9746-7ecd40877540 34 fields · synced Jun 8, 2026