Leica FL800 ULT

GUDID 07630003593587

Surgical microscope fluorescent angiography system

Primary Device ID	07630003593587
NIH Device Record Key	a46e8ae3-729f-49fb-8d7c-1a3184bc9638
Commercial Distribution Status	In Commercial Distribution
Brand Name	Leica FL800 ULT
Version Model Number	000000000010449023
Company DUNS	480198725
Company Name	Leica Microsystems (Schweiz) AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Phone	+1(847)8213462
Email	adam.blunier@leica-microsystem

Device Size Text, specify

Storage Environment Atmospheric Pressure	Between 500 millibar and 1060 millibar
Handling Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *
Handling Environment Atmospheric Pressure	Between 500 millibar and 1060 millibar
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -30 Degrees Celsius and 70 Degrees Celsius

Device Issuing Agency	Device ID
GS1	07630003593587 [Primary]

IZI	System, x-ray, angiographic

Steralize Prior To Use	false
Device Is Sterile	false