Durette® Black Plastic External Shields, small

GUDID 10697660003358

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 ID10697660003358
NIH Device Record Keyc2d9335b-1910-4b84-a5c1-5febf7ae18d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDurette® Black Plastic External Shields, small
Version Model Number23-442B
Company DUNS257382580
Company NameOculo-Plastik Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-381-3292
Emailsales@oculoplastik.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110697660003358 [Primary]

FDA Product Code

IWSShield, Eye, Radiological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10697660003358]

Liquid Chemical;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-19
Device Publish Date2019-11-11

Devices Manufactured by Oculo-Plastik Inc

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10697660002023 - Khan-Jaeger SS Lid Plate for the Laser (non glare), refurb.2022-03-25 The Khan-Jaeger is a curved instrument partially non-glare for blepharoplasty. The usage of this instrument is to block laser be
10697660002047 - Jaeger SS Lid Plate for the Laser (non glare), refurb.2022-03-25 The Khan-Jaeger is a curved instrument partially non-glare for blepharoplasty. The usage of this instrument is to block laser be
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Trademark Results [Durette]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DURETTE
DURETTE
85900389 4447072 Live/Registered
Oculo-Plastik, Inc.
2013-04-10
DURETTE
DURETTE
75383658 2238416 Live/Registered
OCULO-PLASTIK, INC.
1997-11-03
DURETTE
DURETTE
72336586 0899752 Dead/Expired
MONSANTO COMPANY
1969-08-28

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