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

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Durette® II, SS External Ocular Laser Shields, regular (non glare), refurb. FDA UDI
Generic Name: Epiocular radiation shield, reusable FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 21-335R FDA UDI
Description: 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. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660002306 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Durette® II, SS External Ocular Laser Shields, regular (non glare), refurb. by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID

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 dcfd5dda-4177-4987-837a-602b32507c6b 35 fields · synced May 30, 2026