← Back to catalogue

Autoclavable Plastic Ocular Shield, bilateral, large, black, with handle

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 23-206H

by Oculo-Plastik Inc

Identity

Trade Name
Plastic Ocular Shield (large), black with handle EUDAMED
Autoclavable Plastic Ocular Shield, bilateral, large, black, with handle 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
23-206H EUDAMED
23-206BH 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
10697660003129 EUDAMEDFDA UDI
Basic UDI-DI
697660100US EUDAMED
Direct Marketing DI
10697660003129 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
Width — 25 Millimeter FDA UDI
Length — 28 Millimeter FDA UDI

Category: Radiation/mechanical corneal shield, reusable

Autoclavable Plastic Ocular Shield, bilateral, large, black, 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

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

Manufacturer

Manufacturer
Oculo-Plastik Inc

Sources (2)

  • FDA UDI 795e89ae-e5a9-4ac1-a22b-a5b471ea45dd 35 fields · synced Jun 18, 2026
  • EUDAMED f330875b-0a10-4b0c-a5ec-243c530b57d1 61 fields · synced Jun 18, 2026