Identity
- Trade Name
- Monoart FDA UDI
- Generic Name
- Surgical cap, reusable FDA UDI
- Device Name
- This Personal Protective Equipment (P.P.E.) is designed and manufactured exclusively to protect the user against minor or easily reversible impacts resulting from the use of mechanical equipment and/or cleaning products. This P.P.E. also protects against: risks due to contact with hot components having a temperature not exceeding 50°C (normal environmental conditions when working); minor impacts. It is not suitable to protect against the following risks: chemical, heat, fire, cold, poor visibility and electric shock. Monoart bandana with adjustable ties that can fit all sizes. Thanks to the top-quality, colour-fast cotton used, it is autoclavable at 121°C. Single pack, carton of 10 pieces of the same colour. Colour: green. FDA UDI
- Model / Reference
- MONOART BANDANA FDA UDI
- Description
- This Personal Protective Equipment (P.P.E.) is designed and manufactured exclusively to protect the user against minor or easily reversible impacts resulting from the use of mechanical equipment and/or cleaning products. This P.P.E. also protects against: risks due to contact with hot components having a temperature not exceeding 50°C (normal environmental conditions when working); minor impacts. It is not suitable to protect against the following risks: chemical, heat, fire, cold, poor visibility and electric shock. Monoart bandana with adjustable ties that can fit all sizes. Thanks to the top-quality, colour-fast cotton used, it is autoclavable at 121°C. Single pack, carton of 10 pieces of the same colour. Colour: green. FDA UDI
Identifiers
- Catalog Number
- 262001 FDA UDI
- Primary DI / UDI-DI
- E3072620010 FDA UDI
- FDA Product Code
- FYF FDA UDI
- GMDN Term
- Surgical cap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 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 cap, reusable
Monoart by Euronda Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical cap, reusable.
- Encompass — Encompass Group, L.L.C. · Class I
- Monoart — EURONDA SPA · Class I
- Monoart — EURONDA SPA · Class I
- Monoart — EURONDA SPA · Class I
- Monoart — EURONDA SPA · Class I
- Monoart — EURONDA SPA · Class I
- Monoart — EURONDA SPA · Class I
- Monoart — EURONDA SPA · 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 1b215197-da29-4edf-a7df-b6cd9da554bb 34 fields · synced May 31, 2026