Identity
- Trade Name
- Durette® White Plastic External Shields, small FDA UDI
- Generic Name
- Epiocular radiation shield, reusable FDA UDI
- Device Name
- The Durette Plastic External Shields are intended to protect patient’s eyes from apparatuses emitting different wavelengths of non coherent light. They should not be used with Lasers THAT IRRADIATE A COHERENT LIGHT BEAM (spectral irradiance of any wavelength) OR ANY FLASH LAMP OR IPL SYSTEM THAT operates in burst modes that comprise multiple trains of pulses. THEY SHOULD NOT BE USED with high-power, spectral irradiance in the UVB and UVA wavebands or any other spectral irradiance energy or light source. THE DURETTE PLASTIC EXTERNAL SHIELDS can be used with: * Light emitted by fluorescent lamps, bright LEDs or dichroic filament bulbs. * VISIBLE VIOLET LIGHT IN THE RANGE OF 405-420. * Light therapy for skin conditions like psoriasis or eczema which use UVA or UVB PHOTOTHERAPY. * PUVA TREATMENT. * LIGHT THERAPY by Red and/or near infrared (NIR) LEDs. * Photodynamic Therapy (PDT) light sources. * Narrowband Light emitting Diodes (LEDs) - Optimised, via a matrix of LEDs. FDA UDI
- Model / Reference
- 23-442W FDA UDI
- Description
- The Durette Plastic External Shields are intended to protect patient’s eyes from apparatuses emitting different wavelengths of non coherent light. They should not be used with Lasers THAT IRRADIATE A COHERENT LIGHT BEAM (spectral irradiance of any wavelength) OR ANY FLASH LAMP OR IPL SYSTEM THAT operates in burst modes that comprise multiple trains of pulses. THEY SHOULD NOT BE USED with high-power, spectral irradiance in the UVB and UVA wavebands or any other spectral irradiance energy or light source. THE DURETTE PLASTIC EXTERNAL SHIELDS can be used with: * Light emitted by fluorescent lamps, bright LEDs or dichroic filament bulbs. * VISIBLE VIOLET LIGHT IN THE RANGE OF 405-420. * Light therapy for skin conditions like psoriasis or eczema which use UVA or UVB PHOTOTHERAPY. * PUVA TREATMENT. * LIGHT THERAPY by Red and/or near infrared (NIR) LEDs. * Photodynamic Therapy (PDT) light sources. * Narrowband Light emitting Diodes (LEDs) - Optimised, via a matrix of LEDs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10697660003365 FDA UDI
- FDA Product Code
- IWS FDA UDI
- GMDN Term
- Epiocular radiation shield, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.6500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
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
No
FDA UDI
Category: Epiocular radiation shield, reusable
Durette® White Plastic External Shields, small by Oculo-Plastik Inc — 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
- Oculo-Plastik Inc
Sources (1)
- FDA UDI dc94b036-0432-46b1-9e30-fae9fdfebac5 34 fields · synced Jun 8, 2026