Integra® Duo

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences (ireland) Limited

Identity

Trade Name: Integra® Duo FDA UDI
Generic Name: General-purpose light source FDA UDI
Device Name: Integra® Duo Duo Headlight and Carrying Case FDA UDI
Model / Reference: 90600 FDA UDI
Description: Integra® Duo Duo Headlight and Carrying Case FDA UDI

Identifiers

Catalog Number: 90600 FDA UDI
Primary DI / UDI-DI: 10381780491064 FDA UDI
FDA Product Code: FSR FDA UDI
GMDN Term: General-purpose light source FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4335 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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: General-purpose light source

Integra® Duo by Integra Lifesciences (ireland) Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose light source.

Integra® — Integra LifeSciences Production Corporation · Class II
Orascoptic - Endeavour TruColor Headlight System — METREX RESEARCH · Class I
BR Surgical, LLC — BR SURGICAL LLC · Class II
NICO Myriad-LX — NICO Corporation · Class II
Integra® — Integra LifeSciences Production Corporation · Class II
Orascoptic - Endeavour TruColor Headlight System — METREX RESEARCH · Class I
Orascoptic - Endeavour TruColor XL Headlight System — METREX RESEARCH · Class I
Integra® — Integra LifeSciences Production Corporation · Class II

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 II	Pending data

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

Manufacturer

Manufacturer: Integra Lifesciences (ireland) Limited

Sources (1)

FDA UDI ba6a10fc-4a4f-4d6e-adb1-e5640c29b04f 36 fields · synced May 30, 2026