Autoclavable Plastic Ocular Shield, bilateral, x-small, t-yellow, with handle

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Autoclavable Plastic Ocular Shield, bilateral, x-small, t-yellow, with handle FDA UDI
Generic Name: Radiation/mechanical corneal shield, reusable FDA UDI
Device Name: The plastic ocular shields are used to protect the eyes when working with a scalpel, electro-cutter or other energy sources requiring protective plastic shields as the metal would be conductive (ex: RF system). The ocular shields are inserted under the eyelids over the globe, and remain in place for the duration of the intervention. They should not be left in place more than 60 minutes. PLASTIC OCULAR SHIELDS ARE NOT INTENDED FOR USE WITH LASER OR IPL SYSTEMS. FDA UDI
Model / Reference: 23-201YH FDA UDI
Description: The plastic ocular shields are used to protect the eyes when working with a scalpel, electro-cutter or other energy sources requiring protective plastic shields as the metal would be conductive (ex: RF system). The ocular shields are inserted under the eyelids over the globe, and remain in place for the duration of the intervention. They should not be left in place more than 60 minutes. PLASTIC OCULAR SHIELDS ARE NOT INTENDED FOR USE WITH LASER OR IPL SYSTEMS. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660002726 FDA UDI
FDA Product Code: HOY FDA UDI
GMDN Term: Radiation/mechanical corneal shield, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 21 Millimeter FDA UDI
Length — 23 Millimeter FDA UDI

Category: Radiation/mechanical corneal shield, reusable

Autoclavable Plastic Ocular Shield, bilateral, x-small, t-yellow, with handle by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID

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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 40dc2159-2b27-49a9-8a9f-57a1e2ebc045 35 fields · synced May 30, 2026