LEICA FL800

GUDID 07630003576238

Leica Microsystems (Schweiz) AG

Surgical microscope fluorescent angiography system

• Primary Device ID: 07630003576238
• NIH Device Record Key: 8687e8e9-b927-456f-9aee-9fce78829ff6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEICA FL800
• Version Model Number: 000000000010448748
• 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

Customer Support Contacts

• Phone: +1(847)8213462
• Email: adam.blunier@leica-microsystem
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com
• Phone: +1(984)7105152
• Email: Iris.Pohl@leica-microsystems.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage 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
• Storage Environment Atmospheric Pressure: Between 500 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630003576238 [Primary]

FDA Product Code

• IZI: System, x-ray, angiographic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-13