Product Overview

LED LIGHT SOURCE - OME-L200


Device Description

A mains electricity (AC-powered) device that is exclusively designed to provide a microscope with an external source of light to light up the viewing field which may be, e.g., directly under the magnification system (a slide) or a field of surgical intervention. This device may be a simple lamp, or utilize fibreoptic cables to carry a cold light forward to the site. This device is not built into the microscope and must be identified using this GMDN code. If the light source is built-in, then it shall be considered as part of the parent device and the product identification will then follow that of the parent device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: EPT

Device Name: Microscope, Surgical

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4700

Third Party Flag: N

Medical Specialty: SU


Code: IZI

Device Name: System, X-Ray, Angiographic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1600

Third Party Flag: N

Medical Specialty: RA


Device Identifiers

Device Id: 04953170395901

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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