I-Tek I-150 LED Light Source

FDA UDI

Class II (US FDA UDI)

by I-Tek Medical Solutions, Inc.

Identity

Trade Name: I-Tek I-150 LED Light Source FDA UDI
Generic Name: General-purpose light source FDA UDI
Device Name: The LED Light Source is the light source for use with the Medical Illumination Light Enhancement System. It is a compact size with a small footprint, light, easily portable, has infinitely variable light output and is maintenance free with a long lifetime expectancy. FDA UDI
Model / Reference: I-150 FDA UDI
Description: The LED Light Source is the light source for use with the Medical Illumination Light Enhancement System. It is a compact size with a small footprint, light, easily portable, has infinitely variable light output and is maintenance free with a long lifetime expectancy. FDA UDI

Identifiers

Catalog Number: I-150 FDA UDI
Primary DI / UDI-DI: 00869836000307 FDA UDI
FDA Product Code: FCW FDA UDI
GMDN Term: General-purpose light source FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

FDA UDI

Over-the-Counter

Yes

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

Dimensions & Sizes

Size: Width — 4.65 Inch FDA UDI
Depth — 7.25 Inch FDA UDI
Height — 3.32 Inch FDA UDI
Weight — 1.14 Kilogram FDA UDI

Category: General-purpose light source

I-Tek I-150 LED Light Source by I-Tek Medical Solutions, Inc. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: I-Tek Medical Solutions, Inc.

Sources (1)

FDA UDI 3a9a4dae-e9a3-437b-bf63-57b1e59a56df 37 fields · synced May 30, 2026