Identity
- Trade Name
- Monoart FDA UDI
- Generic Name
- Medical equipment drape, single-use, non-sterile FDA UDI
- Device Name
- A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: white FDA UDI
- Model / Reference
- KIT MONOART DENTIST CHAIR COVER FDA UDI
- Description
- A disposable universal dentist chair cover for the protection and safety of patients. Kit containing a headrest cover, a backrest cover and a seat cover made of non-woven polypropylene fabric. Made of 30 g/m2 non-woven fabric. Universal size. Carton of 25 single colour bags. Colour: white FDA UDI
Identifiers
- Catalog Number
- 264002 FDA UDI
- Primary DI / UDI-DI
- E3072640020 FDA UDI
- FDA Product Code
- NRU FDA UDI
- GMDN Term
- Medical equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6250 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: Medical equipment drape, single-use, non-sterile
Monoart by Euronda Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical equipment drape, single-use, non-sterile.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- HENRY SCHEIN — HENRY SCHEIN, INC. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- HENRY SCHEIN — HENRY SCHEIN, INC. · Class I
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
- Phosphor Plate Barrier Envelopes (Size 2) — BURKHART DENTAL SUPPLY CO., THE · 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 83133069-919f-4476-be68-dc2a33d3952a 34 fields · synced May 29, 2026