Identity
- Trade Name
- Monoart FDA UDI
- Generic Name
- Dental suction system cannula, single-use FDA UDI
- Device Name
- Practical kit Monoart containing 8 different disposable products for 500 patients: 500 Towel Up, 500 saliva ejectors fix, 500 plastic cups, 250 tray papers, 200 Masks Pro.3, 160 Aprons PG30/80, 10 EM19 EVO, 2 bags Cotton rolls n.2. Colour: Lime FDA UDI
- Model / Reference
- KIT MONOART® 8P 15,0 FIXED FDA UDI
- Description
- Practical kit Monoart containing 8 different disposable products for 500 patients: 500 Towel Up, 500 saliva ejectors fix, 500 plastic cups, 250 tray papers, 200 Masks Pro.3, 160 Aprons PG30/80, 10 EM19 EVO, 2 bags Cotton rolls n.2. Colour: Lime FDA UDI
Identifiers
- Catalog Number
- 290228 FDA UDI
- Primary DI / UDI-DI
- E30729022813 FDA UDI
- FDA Product Code
- KHR FDA UDI
- GMDN Term
- Dental suction system cannula, single-use 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: Surgical/medical face mask, single-useDental suction system cannula, single-useDental cotton roll
Monoart by Euronda Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental cotton roll.
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- 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 c7e26adf-c057-45b1-8ed8-8757b79c08ef 34 fields · synced May 30, 2026