Durette® II, SS External Ocular Laser Shields, regular (non glare)

GUDID 20697660002297

Durette® II External laser shields are designed to protect patient's eyes during laser treatment. They are installed on the face over the eyelids. It is provided with a fastening system that fits as many people as possible. The regular size is used in most treatments on the face, while the small size is used when the surgeon wants to go closer to the eyes. The entire surface of the device is non-glare treated to diffuse the laser. The medical staff uses the instrument during surgery. It must be cleaned and sterilized before use.

Oculo-Plastik Inc

Epiocular radiation shield, reusable

• Primary Device ID: 20697660002297
• NIH Device Record Key: 343bbde9-49a6-4fe2-8d8c-8665f928ddc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Durette® II, SS External Ocular Laser Shields, regular (non glare)
• Version Model Number: 21-335
• 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: false
• 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	20697660002297 [Primary]

FDA Product Code

• IWS: Shield, Eye, Radiological

Sterilization

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

[20697660002297]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

Devices Manufactured by Oculo-Plastik Inc

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