Identity
- Trade Name
- Monoart FDA UDI
- Generic Name
- Patient examination/treatment drape, single-use FDA UDI
- Device Name
- Roll of 133 patients aprons made from a waterproof polyethylene layer. The perforated tear-off parts make the aprons easy to use. The system with laces, allows to tie apron directly to the patient’s neck. Available in two sizes (120 and 160 cm respectively), these protect patients down to the knee or ankles. Carton of 6 rolls. Dimensions: 120 x 53 cm. Colour: blue. FDA UDI
- Model / Reference
- MONOART® APRON PG 20 XLong FDA UDI
- Description
- Roll of 133 patients aprons made from a waterproof polyethylene layer. The perforated tear-off parts make the aprons easy to use. The system with laces, allows to tie apron directly to the patient’s neck. Available in two sizes (120 and 160 cm respectively), these protect patients down to the knee or ankles. Carton of 6 rolls. Dimensions: 120 x 53 cm. Colour: blue. FDA UDI
Identifiers
- Catalog Number
- 21910151 FDA UDI
- Primary DI / UDI-DI
- E307219101510 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
Similar devices
Also classified as Patient examination/treatment drape, single-use.
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- iSmile — ISMILE DENTAL PRODUCTS INC. · Class I
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- Proback Towels — CROSSTEX INTERNATIONAL, INC. · Class I
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- iSmile — ISMILE DENTAL PRODUCTS INC. · Class I
- Quala — NATIONAL DISTRIBUTION & CONTRACTING, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Euronda Spa
Sources (1)
- FDA UDI 05df7a6b-3661-4685-b695-4d4c65376653 34 fields · synced Jun 6, 2026