Cox® II, SS Ocular Laser Shield, right, medium (non glare) w. handle

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 21-264HR

by Oculo-Plastik Inc

Identity

Trade Name: Stainless Steel Ocular Laser Shield, Right, medium (non glare) with handle EUDAMED
Cox® II, SS Ocular Laser Shield, right, medium (non glare) w. handle FDA UDI
Generic Name: Radiation/mechanical corneal shield, reusable FDA UDI
Device Name: Cox® Stainless Steel Ocular Laser Shield EUDAMED
Cox® II ocular laser shields are intended to protect the eyes during IPL and laser procedures close to the eyes and on the face. They are inserted under the eyelids, on the ocular globes for the length of the procedure. They should not be left in place more than 60 minutes. The posterior polished surface and well-polished edges are intended to avoid corneal abrasions. The anterior surface is non-reflective treated to avoid reflection of the laser beam or IPL light source. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT OR RADIO FREQUENCY. After every case application and before sterilization, always verify visually and manually the condition of both surfaces and edges of the device. For the comfort and safety of the patient during insertion of the ocular shields an ophthalmic topical anaesthetic and ointment (non petroleum based for laser) is recommended. Users must choose a shield size appropriate to the globe. During periorbital surgery the shields should cover the entire globe. FDA UDI
Model / Reference: 21-264HR EUDAMEDFDA UDI
Description: Cox® II ocular laser shields are intended to protect the eyes during IPL and laser procedures close to the eyes and on the face. They are inserted under the eyelids, on the ocular globes for the length of the procedure. They should not be left in place more than 60 minutes. The posterior polished surface and well-polished edges are intended to avoid corneal abrasions. The anterior surface is non-reflective treated to avoid reflection of the laser beam or IPL light source. USE ONLY WITH PURE LASERS OR PURE IPL SYSTEMS. DO NOT USE WITH SYSTEMS THAT ARE INTEGRATED WITH ELECTRIC CURRENT OR RADIO FREQUENCY. After every case application and before sterilization, always verify visually and manually the condition of both surfaces and edges of the device. For the comfort and safety of the patient during insertion of the ocular shields an ophthalmic topical anaesthetic and ointment (non petroleum based for laser) is recommended. Users must choose a shield size appropriate to the globe. During periorbital surgery the shields should cover the entire globe. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660001712 EUDAMEDFDA UDI
Basic UDI-DI: 697660101UU EUDAMED
Direct Marketing DI: 10697660001712 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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 — 23 Millimeter FDA UDI
Length — 25.5 Millimeter FDA UDI

Category: Radiation/mechanical corneal shield, reusable

Cox® II, SS Ocular Laser Shield, right, medium (non glare) w. handle by Oculo-Plastik Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

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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

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Manufacturer

Manufacturer: Oculo-Plastik Inc

Sources (2)

FDA UDI 2cffdef2-5895-44a6-a8b7-2d1b90a1e065 35 fields · synced Jun 19, 2026
EUDAMED 01a4ed06-42a4-4945-9079-3d4a97453817 61 fields · synced Jun 19, 2026