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Autoclavable Plastic Ocular Shield, bilateral, large, t-yellow, with handle

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 23-206YRef 23-206YH

by Oculo-Plastik Inc

Identity

Trade Name
Plastic Ocular Shield (large), yellow EUDAMED
Plastic Ocular Shield (large), yellow with handle EUDAMED
Autoclavable Plastic Ocular Shield, bilateral, large, t-yellow, with handle FDA UDI
Autoclavable Plastic Ocular Shield, bilateral, large, t-yellow FDA UDI
Generic Name
Radiation/mechanical corneal shield, reusable FDA UDI
Device Name
Plastic Ocular Shield EUDAMED
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
23-206YH EUDAMEDFDA UDI
23-206Y EUDAMEDFDA 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
10697660003204 EUDAMEDFDA UDI
10697660003181 EUDAMEDFDA UDI
Basic UDI-DI
697660100US EUDAMED
FDA Product Code
HOY FDA UDI
EMDN Code
T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
GMDN Term
Radiation/mechanical corneal shield, reusable FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
886.4750 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Dimensions & Sizes

Size
Length — 28 Millimeter FDA UDI
Width — 25 Millimeter FDA UDI
Width — 25.5 Millimeter FDA UDI
Length — 28.5 Millimeter FDA UDI

Category: Radiation/mechanical corneal shield, reusable

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

Similar devices

Also classified as Radiation/mechanical corneal shield, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oculo-Plastik Inc

Sources (4)

  • FDA UDI d9fb8e35-0cd8-4ed9-8cef-758c886bf39f 35 fields · synced Jul 30, 2026
  • FDA UDI f30074c9-d7b1-4baa-a656-c6e85f80dd51 35 fields · synced May 30, 2026
  • EUDAMED f8cf2c9e-2381-4554-8853-82f6e849e94b 61 fields · synced Jul 11, 2026
  • EUDAMED bf53847a-8eef-44c2-9be8-31cfbf227199 61 fields · synced Jul 30, 2026