LW Scientific, Inc.

Basic Information

• Brand Name: LW Scientific, Inc.
• Primary DI: 00664816000892
• Version / Model: i4M-BN4A-iSL3
• Catalog Number: i4M-BN4A-iSL3
• Company Name: LW SCIENTIFIC, INC.
• Labeler DUNS: 785335381
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-08
• Public Version: 1
• Public Version Date: 2021-04-16
• Public Version Status: New
• Public Device Record Key: 274e0333-20ab-4ddf-b27c-611904406320

Device Description

i-4 Infinity Semi-Plan Binocular 4 Obj, LED

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: Yes
• Has Manufacturing Date: No
• 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	00664816000892	GS1