FL400

Basic Information

• Brand Name: FL400
• Primary DI: 07630003578089
• Version / Model: 000000000010448770
• Catalog Number: 10448770
• Company Name: Leica Microsystems (Schweiz) AG
• Labeler DUNS: 480198725
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-10
• Public Version: 2
• Public Version Date: 2026-01-16
• Public Version Status: Update
• Public Device Record Key: 9b4914b7-699a-4e6d-bdab-3f3ff25d7cda

Device Description

FL400 for M530 - Accessory for Leica surgical operating microscope systems

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
EPT	MICROSCOPE, SURGICAL	General, Plastic Surgery	878.4700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63714	Surgical microscope filter	An electronic accessory to a surgical microscope designed to filter light to enable fluorescence excitation and visualization of tissues treated with an ultraviolet-excitable agent (e.g., aminolaevulinic acid) during open surgical procedures. It is typically used to view gliomas. It may include a computing component with software to allow for the capture of digital images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630003578089	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify

Storage Conditions

• Type: Special Storage Condition, Specify