OPELAIII Standard Package

FDA UDI

Class I (US FDA UDI)

by Taiyo Corporation

Identity

Trade Name: OPELAIII Standard Package FDA UDI
Generic Name: Head-worn lamp FDA UDI
Device Name: Wearable Surgical Lighting System FDA UDI
Model / Reference: -H FDA UDI
Description: Wearable Surgical Lighting System FDA UDI

Identifiers

Primary DI / UDI-DI: 14589864500107 FDA UDI
FDA Product Code: HPP FDA UDI
FQP FDA UDI
FSQ FDA UDI
GMDN Term: Head-worn lamp FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4335 FDA UDI
878.4580 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Head-worn lamp

OPELAIII Standard Package by Taiyo Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Taiyo Corporation

Sources (1)

FDA UDI 9fb771d6-42da-4a02-a105-2c7e17172995 34 fields · synced Jun 8, 2026