SEILER MEDICAL DIVISION

Basic Information

• Brand Name: SEILER MEDICAL DIVISION
• Primary DI: 00852728008864
• Version / Model: MLX817-LED
• Company Name: SEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATED
• Labeler DUNS: 006265334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-02
• Public Version: 1
• Public Version Date: 2023-03-10
• Public Version Status: New
• Public Device Record Key: 80aff47d-c876-47a3-9902-7b92627e941d

Device Description

The Microlux IV compound microscope with optional video or digital configurations as well as Phase Contrast, LED, Simple Polarization, and MOH's for Dermatology procedures. The Microlux comes with five Infinity Corrected Plan Objectives: 4x, 10x, 20x, 40x, 100x for sharper images and virtually no aberrations.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IBJ	Light, Microscope	Pathology	864.3600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35484	Basic light microscope	A magnification instrument designed with a standard microscope configuration [the object viewed through an ocular(s) from above] used to magnify and study specimens and small objects by transmitted visible light. It is widely used in laboratories and for research and in healthcare facilities where there is a need for such magnification. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852728008864	GS1