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Autoclavable Plastic Ocular Shield, bilateral, medium, t-yellow

FDA UDIEUDAMED

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name
Autoclavable Plastic Ocular Shield, bilateral, medium, t-yellow 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
23-204YE 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
10697660003037 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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 — 27.5 Millimeter FDA UDI
Width — 24.5 Millimeter FDA UDI

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

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 (2)

  • FDA UDI e0475a98-dedd-48b8-b760-db27a6b4bbeb 36 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026