SEILER MEDICAL DIVISION

Basic Information

• Brand Name: SEILER MEDICAL DIVISION
• Primary DI: 00860010027707
• Version / Model: WLB814
• 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: aa7bee5a-4f86-43d5-bfd7-f4dd69e57977

Device Description

Economically priced routine microscope offering all the standard features of higher-priced scopes including halogen 6V 20W Halogen illumination, coaxial coarse and fine focusing, Finity Seidentopf binocular head, right-hand graduated mechanical stage, 10x wide-field eyepieces with 20mm FOV and 4 semi-plan achromat objectives including 4, 10, 40, and 100x oil objective, all mounted on a ball-bearing inward quadruple click-stop nosepiece.

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	00860010027707	GS1