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Laser kit

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name
Laser kit FDA UDI
Generic Name
Corneal shield applicator FDA UDI
Device Name
Ocular Laser Shields (1 Regular Durette® II and 2 Medium Cox® II) (non glare) + spare headband & a case with 2 suction cups FDA UDI
Model / Reference
21-330 FDA UDI
Description
Ocular Laser Shields (1 Regular Durette® II and 2 Medium Cox® II) (non glare) + spare headband & a case with 2 suction cups FDA UDI

Identifiers

Primary DI / UDI-DI
30697660002256 FDA UDI
FDA Product Code
KYE FDA UDI
HOY FDA UDI
IWS FDA UDI
GMDN Term
Corneal shield applicator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
886.5420 FDA UDI
886.4750 FDA UDI
892.6500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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

Category: Radiation/mechanical corneal shield, reusableEpiocular radiation shield, reusableCorneal shield applicator

Laser kit by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Corneal shield applicator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oculo-Plastik Inc

Sources (1)

  • FDA UDI 7c449f12-e7c2-4bef-887e-56f34ec68717 34 fields · synced Jun 1, 2026