Leica FL800 ULT

Basic Information

• Brand Name: Leica FL800 ULT
• Primary DI: 07630003593587
• Version / Model: 000000000010449023
• Company Name: Leica Microsystems (Schweiz) AG
• Labeler DUNS: 480198725
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-20
• Public Version: 1
• Public Version Date: 2018-12-21
• Public Version Status: New
• Public Device Record Key: a46e8ae3-729f-49fb-8d7c-1a3184bc9638

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: No
• 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
IZI	System, x-ray, angiographic	Radiology	892.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57883	Surgical microscope fluorescent angiography system	A non-sterile, mains electricity (AC-powered) device assembly designed for viewing intraoperative blood flow in the cerebral vascular area, in bypass grafts during coronary artery bypass graft (CABG) surgery, and during plastic and reconstructive surgery. It enables a surgical microscope to produce excitation light and resolve fluorescence from the fluorescent agent indocyanine green (ICG). Fluorescent signals depict the distribution of the infrared dye in the patient's blood vessels during the operation. The system is attached to a compatible surgical microscope and typically includes an ICG filter, a near infrared (NIR) charge-coupled device (CCD) video camera, and connecting cables.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630003593587	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Not Applicable

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Handling Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius
• Type: Special Storage Condition, Specify
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Handling Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -30 – 70 Degrees Celsius