Black Durette® Plastic External Shields, regular - The Durette Plastic External Shields are intended - Oculo-Plastik Inc

Duns Number:257382580

Device Description: The Durette Plastic External Shields are intended to protect patient’s eyes from apparatus 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.

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More Product Details

Catalog Number

-

Brand Name

Black Durette® Plastic External Shields, regular

Version/Model Number

23-445B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IWS

Product Code Name

Shield, Eye, Radiological

Device Record Status

Public Device Record Key

61cf3c74-1319-4d07-8ae3-ebfc9147eb80

Public Version Date

November 19, 2019

Public Version Number

1

DI Record Publish Date

November 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCULO-PLASTIK INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 192
2 A medical device with a moderate to high risk that requires special controls. 88