Identity
- Trade Name
- Monoart FDA UDI
- Generic Name
- Patient examination/treatment drape, single-use FDA UDI
- Device Name
- Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: blue FDA UDI
- Model / Reference
- MONOART APRON PG30 FDA UDI
- Description
- Roll of 60 patient aprons made of 1 ply paper + 1 ply of waterproof polyethylene. Size 810 x 530 mm. Carton of 6 rolls. Colour: blue FDA UDI
Identifiers
- Catalog Number
- 22010311 FDA UDI
- Primary DI / UDI-DI
- E307220103110 FDA UDI
- FDA Product Code
- KHR FDA UDI
- GMDN Term
- Patient examination/treatment drape, 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: Patient examination/treatment drape, single-use
Monoart by Euronda Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 7104fc5c-25e3-4525-a581-be3588a717a3 34 fields · synced May 30, 2026