Autoclavable Plastic Ocular Shield, bilateral, medium, black

FDA UDIEUDAMED

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Autoclavable Plastic Ocular Shield, bilateral, medium, black 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: 23-204B 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: 10697660002948 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 — 24.5 Millimeter FDA UDI
Length — 27.5 Millimeter FDA UDI

Category: Radiation/mechanical corneal shield, reusable

Autoclavable Plastic Ocular Shield, bilateral, medium, black by Oculo-Plastik Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Radiation/mechanical corneal shield, reusable.

MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
SOFT CARE — BOURNAS MEDICALS · Class I
STOCKINETTE ROULEE 1/1 COTON ECRU 15x150 M6 — MAILL'TUB · Class I
CONCHIGLIA OCULARE — Surgika srl · Class I
MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
Sani-Tab Chain-Free Econoback Towels — CROSSTEX INTERNATIONAL, INC. · Class I
Champ Fenêtré Adhésif — JiangSu MedPlus Non-Woven Manufacturer Co., Ltd · Class I
Simplex-Plus Maxi kék nyálkendő — Dentalia Dentálgyártmány Kft. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Oculo-Plastik Inc

Sources (2)

FDA UDI fcf307f2-bf34-4718-a359-d32acaacadc8 35 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 18, 2026