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

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name
Durette® II, SS External Ocular Laser Shields, regular (non glare) 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
21-335 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
20697660002297 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
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Epiocular radiation shield, reusable

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

Similar devices

Also classified as Epiocular radiation shield, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oculo-Plastik Inc

Sources (1)

  • FDA UDI 343bbde9-49a6-4fe2-8d8c-8665f928ddc6 34 fields · synced Jun 6, 2026