Black Durette® Plastic External Shields, regular

GUDID 10697660003372

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.

Oculo-Plastik Inc

Epiocular radiation shield, reusable

• Primary Device ID: 10697660003372
• NIH Device Record Key: 61cf3c74-1319-4d07-8ae3-ebfc9147eb80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Black Durette® Plastic External Shields, regular
• Version Model Number: 23-445B
• Company DUNS: 257382580
• Company Name: Oculo-Plastik Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 514-381-3292
• Email: sales@oculoplastik.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10697660003372 [Primary]

FDA Product Code

• IWS: Shield, Eye, Radiological

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10697660003372]

Liquid Chemical;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-19
• Device Publish Date: 2019-11-11

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